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Ivermectin

Detailed information about Ivermectin

Official label facts Owner quick guide first Marketing clearly labeled
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Pet Owner Quick Guide

Start here: what this medicine is for, what it does, and when it's usually needed.

Usually used for:

For the effective treatment and control of the following parasites of cattle: Gastrointestinal Roundworms (adults and fourth-stage larvae): Ostertagia ostertagi (including inhibited O. ostertagi ), O. lyrata , Haemonchus...

What it does:

Used monthly for heartworm prevention in dogs and cats; also controls certain intestinal parasites.

When it's needed:

Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses.

Call your vet sooner if you notice:

  • Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses.

Commonly reported reactions:

  • (1 reports)
  • (1 reports)
  • (1 reports)

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
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Image for Ivermectin

Ivermectin

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Boehringer lngelheim Animal Health USA, Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Boehringer lngelheim Animal Health USA, Inc.
Form: Chewable Tablets, Drench, Injectable Solution, Injection, Liquid, Liquid (Solution)
Identifiers:
ANADA: 200202 ANADA: 200219 ANADA: 200228 ANADA: 200270 ANADA: 200272 ANADA: 200286 ANADA: 200292 ANADA: 200297 ANADA: 200320 ANADA: 200321 ANADA: 200326 ANADA: 200327 ANADA: 200338 ANADA: 200340 ANADA: 200341 ANADA: 200390 ANADA: 200429 ANADA: 200436 ANADA: 200437 ANADA: 200447
Source metadata:

Warnings / Contraindications

Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses.

  • High: Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
7
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
1 Cat 1
1 Cat 1
1 Cat 1
1 Cat 1
1 Dog 1
1 Cat 1
1 Cat 1
1 Cat 0

Species coverage: Cat (24) Dog (8)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Dog Non-serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Non-serious - 1
Cat Serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Cat Non-serious - 1
Dog Non-serious - 1
Cat Serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Cat Non-serious - 1
Source metadata:

Storage & Handling

Store at controlled room temperature (20–25°C / 68–77°F); protect from light and moisture. Keep out of reach of children.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 144 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

Source metadata:

Promotional Materials (Marketing)

This content is marketing material and not clinical guidance.

No marketing assets are linked yet.

No source yet.

Source metadata: No source yet.
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Technical appendix (vet reference)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 7:40 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:01 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 12, 2026, 10:41 PM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Acarexx® Advantage® DUO Animec™ Plus BMD® / Ivomec® Premix for Swine Bimectin® Bimectin® Injection for Cattle and Swine Bimectin® Plus Duocare™ EQVALAN® Equell® Equimax® Eqvalan® Injection Eqvalan® Oral Liquid For Horses Heartgard® Chewables For Dogs Heartgard® Plus Heartgard® Tablets Heartgard 30® Heartgard® for Cats IVERHART MAX® Chew IVOMEC® plus LINCOMIX® Iverhart Max® Iverhart™ Tablets Ivermectin Chewable Tablets Ivermectin Injection Ivermectin Paste 1.87 % Ivermectin Paste 1.87% Ivermectin Pour-On for Cattle Phoenectin™ Pour-On for Cattle Phoenectin™ Phoenectin® Iversol Liquid for Horses Ivomec® 1% Injection Ivomec® .27% Injection Grower And Feeder Pigs Ivomec® Injection for Cattle Ivomec® 1% Injection for Cattle And Swine Ivomec® Cattle Paste 0.153% Ivomec® Liquid Ivomec® Pour-On Ivomec® Premix for Swine Ivomec® Sustained-Release Bolus for Cattle Noromectin® Noromectin® Plus Noromectin® Pour-On for Cattle Phoenectin® Phoenectin® Paste 1.87% Primectin™ Equine Oral Liquid Privermectin® Privermectin™ Drench for Sheep SparMectin Plus Clorsulon SparMectin-E Tri-Heart Plus Chewable Tablets ZIMECTERIN® Gold Paste Zimecterin-EZ™ ivomec® Plus
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Adults, Beef, Beef And Dairy, Bison, Breeding, Calves 3 months and older, Cat And Kitten, Cats and kittens, Dairy, Dog, Finishing, Fox, Growing, Growing and finishing pigs up to 250 pounds, Horse, No Use Class Stated Or Implied, No use class stated or implied, Reindeer, Sheep, Sows with litters or about to farrow, Up to 70 pounds
Rx/OTC: OTC, RX, RX/OTC, VFD
Form/route: Chewable Tablets, Drench, Injectable Solution, Injection, Liquid, Liquid (Solution), Liquid (Suspension), Medicated Feed, Paste, Solution, Solution-Sterile, Sustained Release Bolus, Tablet, Tablet (Chewable), Top Dressing In Feed, Type A Medicated Article • Intramuscular, Nasogastric, Oral, Subcutaneous, Topical
Applications: NADA 140-833 • NADA 131-392 • NADA 141-421 • ANADA 200-338 • ANADA 200-292 • NADA 140-841 • NADA 127-443 • NADA 140-439 • ANADA 200-564 • ANADA 200-436 • NADA 141-214 • ANADA 200-506 • ANADA 200-466 • NADA 141-441 • ANADA 200-437 • NADA 141-054 • ANADA 200-450 • ANADA 200-272 • NADA 134-314 • NADA 141-097 • ANADA 200-340 • ANADA 200-341 • ANADA 200-286 • NADA 141-241 • ANADA 200-326 • ANADA 200-447 • NADA 140-886 • NADA 128-409 • NADA 140-974 • ANADA 200-390 • NADA 141-215 • ANADA 200-219 • ANADA 200-228 • ANADA 200-202 • NADA 141-174 • NADA 141-208 • ANADA 200-320 • NADA 141-078 • NADA 140-971 • NADA 138-412 • NADA 141-257 • ANADA 200-270 • ANADA 200-297 • ANADA 200-429 • NADA 137-006 • NADA 140-988 • ANADA 200-321 • ANADA 200-327
Documents: 89 (FOI: 77) • SPL: 55 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 56 • Cat 8 • View
Case summaries: 11 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B82.9 ICD10_CM: B88.1
Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses. (Contraindication, High)
Top reaction signals
Abnormal radiograph finding (1) Accidental exposure (1) Administration error NOS (1) Aggression (1) Anorexia (1) Anxiety (1) Ataxia (1) Behavioural disorder NOS (1) Bumping into walls (1) Bumps on skin (1) Cyanotic spots/blotchy skin (1) Death (1) Decreased appetite (1) Decreased cholesterol (total) (1) Diarrhoea (1) Dilated pupils (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200202 ANADA: 200219 ANADA: 200228 ANADA: 200270 ANADA: 200272 ANADA: 200286 ANADA: 200292 ANADA: 200297 ANADA: 200320 ANADA: 200321 ANADA: 200326 ANADA: 200327 ANADA: 200338 ANADA: 200340 ANADA: 200341 ANADA: 200390 ANADA: 200429 ANADA: 200436 ANADA: 200437 ANADA: 200447 ANADA: 200450 ANADA: 200466 ANADA: 200506 ANADA: 200564
Package NDC Product NDC Form / Route Status
0010-4012-01 0010 -
0010-4012-02 0010 -
0010-4012-03 0010 -
0010-4012-04 0010 -
0010-4013-01 0010 -
0010-4013-02 0010 -
0010-4013-03 0010 -
0010-4013-04 0010 -
0010-4014-01 0010 -
0010-4014-02 0010 -
0010-4014-03 0010 -
0010-4014-04 0010 -
0010-4734-01 0010 -
0010-4734-02 0010 -
0010-4734-03 0010 -
0010-4734-04 0010 -
0010-4734-05 0010 -
0010-4743-01 0010 -
0010-4743-02 0010 -
0010-4743-03 0010 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • ucm049956.pdf • FOI summary • Official • Sept. 10, 2025
    FDA FOI summary for application 140833
  • N140833 Supp_2_24_1997.pdf • FOI summary • Official • Sept. 10, 2025
    FDA FOI summary for application 140833
  • N140833_Supp_04_01_1999.pdf • FOI summary • Official • Sept. 10, 2025
    FDA FOI summary for application 140833
  • ucm062428.pdf • FOI summary • Official • Sept. 10, 2025
    FDA FOI summary for application 140833
  • UCM417726.pdf • FOI summary • Official • Sept. 10, 2025
    FDA FOI summary for application 140833
  • UCM468909.pdf • FOI summary • Official • Aug. 28, 2024
    FDA FOI summary for application 131392
  • UCM408781.pdf • FOI summary • Official • May 15, 2024
    FDA FOI summary for application 141421
  • ucm061802.pdf • FOI summary • Official • Feb. 8, 2024
    FDA FOI summary for application 200338
  • ucm061720.pdf • FOI summary • Official • Dec. 26, 2023
    FDA FOI summary for application 200292
  • N140841_Org_08_30_1990.pdf • FOI summary • Official • Nov. 3, 2023
    FDA FOI summary for application 140841
  • N140841_Supp_6_5_1997.pdf • FOI summary • Official • Nov. 3, 2023
    FDA FOI summary for application 140841
  • ucm049946.pdf • FOI summary • Official • Nov. 3, 2023
    FDA FOI summary for application 140841
  • UCM388267.pdf • FOI summary • Official • May 3, 2023
    FDA FOI summary for application 200564
  • N140439_Orig_9_8_1987.pdf • FOI summary • Official • May 3, 2023
    FDA FOI summary for application 140439
  • ucm049866.pdf • FOI summary • Official • May 3, 2023
    FDA FOI summary for application 140439
  • ucm061369.pdf • FOI summary • Official • March 13, 2023
    FDA FOI summary for application 200436
  • ucm118009.pdf • FOI summary • Official • July 26, 2021
    FDA FOI summary for application 141214
  • ucm118011.pdf • FOI summary • Official • July 26, 2021
    FDA FOI summary for application 141214
  • ucm118012.pdf • FOI summary • Official • July 26, 2021
    FDA FOI summary for application 141214
  • FOI Summary oA 200-506 Approved February 16, 2021.pdf • FOI summary • Official • March 1, 2021
    FDA FOI summary for application 200506
  • UCM326917.pdf • FOI summary • Official • March 1, 2021
    FDA FOI summary for application 200466
  • FOI Summary sA 200-466 Approved February 8, 2021.pdf • FOI summary • Official • March 1, 2021
    FDA FOI summary for application 200466
  • FOI Summary oN 141-441 Approved December 11, 2017.pdf • FOI summary • Official • Nov. 19, 2020
    FDA FOI summary for application 141441
  • ucm061370.pdf • FOI summary • Official • Sept. 22, 2020
    FDA FOI summary for application 200437
  • ucm061372.pdf • FOI summary • Official • Sept. 22, 2020
    FDA FOI summary for application 200437
  • UCM488648.pdf • FOI summary • Official • Sept. 18, 2020
    FDA FOI summary for application 141054
  • FOI Summary oA 200-450 Approved January 31, 2019.pdf • FOI summary • Official • Feb. 26, 2020
    FDA FOI summary for application 200450
  • ucm061697.pdf • FOI summary • Official • Dec. 20, 2019
    FDA FOI summary for application 200272
  • ucm061699.pdf • FOI summary • Official • Dec. 20, 2019
    FDA FOI summary for application 200272
  • ucm069869.pdf • FOI summary • Official • Oct. 29, 2019
    FDA FOI summary for application 134314
  • ucm069870.pdf • FOI summary • Official • Oct. 29, 2019
    FDA FOI summary for application 134314
  • ucm117110.pdf • FOI summary • Official • April 26, 2019
    FDA FOI summary for application 141097
  • ucm061805.pdf • FOI summary • Official • March 17, 2019
    FDA FOI summary for application 200340
  • UCM217614.pdf • FOI summary • Official • March 17, 2019
    FDA FOI summary for application 200340
  • ucm061806.pdf • FOI summary • Official • March 16, 2019
    FDA FOI summary for application 200341
  • UCM388182.pdf • FOI summary • Official • March 16, 2019
    FDA FOI summary for application 200341
  • ucm061713.pdf • FOI summary • Official • March 15, 2019
    FDA FOI summary for application 200286
  • A200286_Supp_12_18_2008_dup.pdf • FOI summary • Official • March 15, 2019
    FDA FOI summary for application 200286
  • ucm118058.pdf • FOI summary • Official • March 15, 2019
    FDA FOI summary for application 141241
  • UCM277818.pdf • FOI summary • Official • Oct. 2, 2018
    FDA FOI summary for application 200447

Data Sources & Revision History

Every non-trivial field is expected to include provenance and update timestamps.

Official 80 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • overdose_info: High doses can cause neurologic symptoms (tremors, ataxia, seizures, coma). Immediate veterinary care is necessary in case of significant overdose. (Clinical, 2026-02-12)
  • storage_handling: Store at controlled room temperature (20–25°C / 68–77°F); protect from light and moisture. Keep out of reach of children. (Clinical, 2026-02-12)
  • contraindications: Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses. (Official, 2026-02-12)
  • side_effects: At preventive doses, side effects are rare; occasional lethargy or mild GI upset. Over-sensitivity possible in some herding breeds. (Official, 2026-02-12)
  • usage: Used monthly for heartworm prevention in dogs and cats; also controls certain intestinal parasites. (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
ivomec® Plus
OTC
Clorsulon Ivermectin
Injection • Subcutaneous
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 140-833 Approved Sep 10, 2025
Ivomec® Liquid
OTC
Ivermectin
Drench • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 131-392 Approved Aug 28, 2024
Duocare™
OTC
Ivermectin Praziquantel
Paste • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA Inc. NADA 141-421 W May 15, 2024
Tri-Heart Plus Chewable Tablets
RX
Ivermectin Pyrantel Pamoate
Tablet (Chewable) • Oral
Label highlights
Official documents
Diamond Animal Health, Inc. ANADA 200-338 Approved Feb 8, 2024
Iversol Liquid for Horses
RX
Ivermectin
Liquid • Oral, Nasogastric
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-292 W Dec 26, 2023
Ivomec® Pour-On
OTC
Ivermectin
Solution • Topical
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 140-841 Approved Nov 3, 2023
Eqvalan® Injection
RX
Ivermectin
Liquid (Solution) • Intramuscular
Label highlights
Official documents
Boehringer lngelheim Animal Health USA Inc. NADA 127-443 W May 3, 2023
Eqvalan® Oral Liquid For Horses
RX
Ivermectin
Liquid • Nasogastric, Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA Inc. NADA 140-439 W May 3, 2023
Ivermectin Paste 1.87%
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA Inc. ANADA 200-564 W May 3, 2023
Noromectin® Plus
OTC
Clorsulon Ivermectin
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-436 Approved Mar 13, 2023
ZIMECTERIN® Gold Paste
OTC
Ivermectin Praziquantel
Paste • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 141-214 Approved Jul 26, 2021
Animec™ Plus
OTC
Ivermectin
Injectable Solution • Subcutaneous
Label highlights
Official documents
Chanelle Pharmaceuticals Manufacturing Ltd. ANADA 200-506 Approved Mar 1, 2021
SparMectin Plus Clorsulon
OTC
Clorsulon Ivermectin
Injectable Solution • Subcutaneous
Label highlights
Official documents
Sparhawk Laboratories, Inc. ANADA 200-466 Approved Mar 1, 2021
IVERHART MAX® Chew
RX
Ivermectin Praziquantel Pyrantel Pamoate
Chewable Tablets • Oral
Label highlights
Official documents
Virbac AH, Inc. NADA 141-441 Approved Nov 19, 2020
Noromectin®
OTC
Ivermectin
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-437 Approved Sep 22, 2020
IVOMEC® plus LINCOMIX®
VFD
Ivermectin Lincomycin
Type A Medicated Article • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA Inc. NADA 141-054 W Sep 18, 2020
Bimectin® Plus
OTC
Clorsulon Ivermectin
Injectable Solution • Subcutaneous
Label highlights
Official documents
Bimeda Animal Health Limited ANADA 200-450 Approved Feb 26, 2020
Noromectin® Pour-On for Cattle
OTC
Ivermectin
Liquid (Solution) • Topical
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-272 Approved Dec 20, 2019
EQVALAN®
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 134-314 Approved Oct 29, 2019
BMD® / Ivomec® Premix for Swine
OTC
Bacitracin methylenedisalicylate Ivermectin
Medicated Feed • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 141-097 Approved Apr 26, 2019
Privermectin®
OTC
Ivermectin
Liquid (Solution) • Topical
Label highlights
Official documents
First Priority, Inc. ANADA 200-340 Approved Mar 17, 2019
SparMectin-E
RX
Ivermectin
Liquid (Suspension) • Oral, Nasogastric
Label highlights
Official documents
Sparhawk Laboratories, Inc. ANADA 200-341 Approved Mar 16, 2019
Phoenectin® Paste 1.87%
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Elanco US Inc. ANADA 200-286 Approved Mar 15, 2019
Zimecterin-EZ™
OTC
Ivermectin
Top Dressing In Feed • Oral
Label highlights
Official documents
Farnam Companies, Inc. NADA 141-241 Approved Mar 15, 2019
Bimectin®
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Bimeda Animal Health Limited ANADA 200-326 Approved Oct 2, 2018
Bimectin® Injection for Cattle and Swine
RX/OTC
Ivermectin
Solution • Subcutaneous
Label highlights
Official documents
Bimeda Animal Health Limited ANADA 200-447 Approved Oct 2, 2018
Heartgard® Chewables For Dogs
RX
Ivermectin
Tablet (Chewable) • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 140-886 Approved Jun 27, 2018
Ivomec® 1% Injection Ivomec® .27% Injection Grower And Feeder Pigs Ivomec® Injection for Cattle Ivomec® 1% Injection for Cattle And Swine
RX/OTC
Ivermectin
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 128-409 Approved Jun 18, 2018
Ivomec® Premix for Swine
OTC
Ivermectin
Medicated Feed • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 140-974 Approved Jun 13, 2018
Ivermectin Paste 1.87 %
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-390 Approved Dec 27, 2017
Equimax®
OTC
Ivermectin Praziquantel
Paste • Oral
Label highlights
Official documents
Virbac AH, Inc. NADA 141-215 Approved Dec 18, 2017
Ivermectin Pour-On for Cattle Phoenectin™ Pour-On for Cattle Phoenectin™ Phoenectin®
OTC
Ivermectin
Liquid (Solution) • Topical
Label highlights
Official documents
Huvepharma EOOD ANADA 200-219 Approved Jul 12, 2017
Phoenectin®
OTC
Ivermectin
Liquid (Solution) • Subcutaneous
Label highlights
Official documents
Huvepharma EOOD ANADA 200-228 Approved Jul 12, 2017
Phoenectin®
RX
Ivermectin
Liquid (Solution) • Oral, Nasogastric
Label highlights
Official documents
Elanco US Inc. ANADA 200-202 Approved May 22, 2017
Acarexx®
RX
Ivermectin
Liquid (Suspension) • Topical
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 141-174 Approved Jun 1, 2016
Advantage® DUO
RX
Imidacloprid Ivermectin
Liquid (Solution) • Topical
Label highlights
Official documents
Elanco US Inc. NADA 141-208 Approved Jun 1, 2016
Equell®
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Virbac AH, Inc. ANADA 200-320 Approved Jun 1, 2016
Heartgard® for Cats
RX
Ivermectin
Tablet (Chewable) • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 141-078 Approved Jun 1, 2016
Heartgard® Plus
RX
Ivermectin Pyrantel Pamoate
Tablet (Chewable) • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 140-971 Approved Jun 1, 2016
Heartgard® Tablets Heartgard 30®
RX
Ivermectin
Tablet • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 138-412 Approved Jun 1, 2016
Iverhart Max®
RX
Ivermectin Praziquantel Pyrantel Pamoate
Tablet (Chewable) • Oral
Label highlights
Official documents
Virbac AH, Inc. NADA 141-257 Approved Jun 1, 2016
Iverhart™ Tablets
RX
Ivermectin
Tablet • Oral
Label highlights
Official documents
Virbac AH, Inc. ANADA 200-270 Approved Jun 1, 2016
Ivermectin Chewable Tablets
RX
Ivermectin
Tablet (Chewable) • Oral
Label highlights
Official documents
Cronus Pharma Specialities India Private Ltd. ANADA 200-297 Approved Jun 1, 2016
Ivermectin Injection
Ivermectin
Solution-Sterile • Subcutaneous
Label highlights
Official documents
Sparhawk Laboratories, Inc. ANADA 200-429 Approved Jun 1, 2016
Ivomec® Cattle Paste 0.153%
OTC
Ivermectin
Paste • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 137-006 Approved Jun 1, 2016
Ivomec® Sustained-Release Bolus for Cattle
OTC
Ivermectin
Sustained Release Bolus • Oral
Label highlights
Official documents
Boehringer lngelheim Animal Health USA, Inc. NADA 140-988 Approved Jun 1, 2016
Primectin™ Equine Oral Liquid
RX
Ivermectin
Liquid (Solution) • Oral, Nasogastric
Label highlights
Official documents
First Priority, Inc. ANADA 200-321 Approved Jun 1, 2016
Privermectin™ Drench for Sheep
OTC
Ivermectin
Drench • Oral
Label highlights
Official documents
First Priority, Inc. ANADA 200-327 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Beef • Dairy, not breeding age
Composition / specifications
10 mg/mL ivermectin and 100 mg/mL clorsulon
Cattle
Indication

For the effective treatment and control of the following parasites of cattle:
Gastrointestinal Roundworms (adults and fourth-stage larvae): Ostertagia ostertagi (including inhibited O. ostertagi), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Bunostomum phlebotomum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Oesophagostomum radiatum
Lungworms (adults and fourth-stage larvae): Dictyocaulus viviparus
Liver Flukes: Fasciola hepatica (adults only)
Cattle Grubs (parasitic stages): Hypoderma bovis, H. lineatum
Sucking Lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus
Mange Mites (cattle scab): Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis
Persistent Activity: IVOMEC Plus Injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment.

Dosage

Give only by subcutaneous injection at a dose volume of 1 mL (10 milligrams of ivermectin and 100 milligrams of clorsulon) per 110 pounds (50 kg) body weight.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Sheep, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 10 milligrams ivermectin.
Sheep
Indication

For treatment and control of the adult and fourth-stage larvae of the following gastrointestinal roundworms - Haemonchus contortus, H. placei (adults only), Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults only), C. curticei, Oesophagostomum columbianum, O. venulosum (adults only), Nematodirus battus, N. spathiger, S. papillosus (adults only), Chabertia ovina (adult only), Trichuris ovis (adults only); lungworms (D. filaria); and all larval stages of the nasal bot Oestrus ovis.

Dosage
200 micrograms per kilogram (3 milliliter per 26 pounds) of body weight as a single dose oral drench.
Limitations
For use in sheep only. Do not use in other animal species as severe adverse reactions, including fatalities in dogs, may result. Do not treat sheep within 11 days of slaughter.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Each milligram of Duocare™ paste contains 0.0187 mg (1.87%) ivermectin and 0.2338 mg (23.38%) praziquantel. Each syringe contains 113.75 mg of ivermectin and 1421.5 mg of praziquantel.
Horses
Indication
For the treatment and control of the following parasites in horses over 5 months of age: Tapeworms Anoplocephala perfoliata; Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp. Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum; Small Strongyles - Fourth-stage larvae; Pinworms (adults and fourth-stage larvae)- Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel (1.14 mg/lb).
Limitations
Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.
Dogs
Indication
Ivermectin: to prevent canine heartworm diseases by eliminating the tissue larval stage of Dirofilaria immitis for a month (30 days) after infection. Pyrantel pamoate: for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, A braziliense, and Uncinaria stenocephala.
Dosage
A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight. up to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate 26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate 51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate
Limitations
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Each milliliter contains 10 milligrams of ivermectin.
Horses
Indication
For treatment and control of: Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
200 micrograms (mcg) per kilogram (/kg) of body weight as a single dose by stomach tube or as an oral drench.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to us by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, not breeding age
Composition / specifications
Each milliliter of solution contains 5 milligrams of ivermectin.
Cattle
Indication

It is used topically for the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia species, Oesophagostomum radiatum; (adults), Strongyloides papillosus, Trichuris species; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparous; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Sarcoptes scabei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; horn flies Haematobia irritans. It also controls infections and prevents reinfection with O. radiatum and D. viviparous for 28 days after treatment, C. punctate and T. axei for 21 days after treatment, H. placei, C. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 days after treatment.

Dosage
One milliliter per 22 pounds of body weight.
Limitations
Do not treat cattle within 48 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product on preruminating cales. Do not use on calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Each milliliter of sterile aqueous solution contains 20 milligrams of ivermectin (2 percent).
Horses
Indication
It is used in horses for the treatment and control of large strongyles (adult) (Strongylus vulgaris, Strongylus edentatus, Triodontophorus species), small strongyles (adult and fourth stage larvae) (Cyathostomum species, Cylicocyclus species, Cylicostephanus species), pinworms (adult and fourth-stage larvae) (Oxyuris equi), large roundworms (adult) (Parascaris equorum), hairworms (adult) (Trichostrongylus axei), large mouth stomach worms (adult) (Habronema muscae), neck threadworms (microfilariae) (Onchocerca species), and stomach bots (Gastrophilus species).
Dosage
20 milligrams per 100 kilograms (220 pounds) of body weight. For intramuscular use.
Limitations
Do not use intravenously. Not for use in horses intended for food. Effects of this drug on pregnant mares have not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Each milliliter contains 10 milligrams of ivermectin.
Horses
Indication
For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentates (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large-mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third- stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca species.
Dosage
91 mcg ivermectin per pound (200 micrograms per kilogram) of body weight as a single dose.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to us by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
1.87% ivermectin
Label highlights
Indication
Ivermectin (ivermectin) Paste 1.87% provides effective treatment and control of the following parasites in horses.

  • Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum;
  • Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;
  • Small Strongyles - Fourth-stage larvae;
  • Pinworms (adults and fourth-stage larvae) - Oxyuris equi;
  • Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum;
  • Hairworms (adults) - Trichostrongylus axei;
  • Large-mouth Stomach Worms (adults) - Habronema muscae;
  • Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis;
  • Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi;
  • Intestinal Threadworms (adults) - Strongyloides westeri;
  • Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
  • Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
Each syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight
Limitations
For oral use only. Do not use in horses intended for human consumption. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism

FDA page: Open in Animal Drugs @ FDA

Species: Beef, excluding veal calves • Dairy, not breeding age
Composition / specifications
Each milliliter of sterile aqueous solution contains 10 milligrams (1 percent) of ivermectin and 100 milligrams (10 percent) of clorsulon
Cattle
Indication
It is used for the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); liver flukes (adults only) (Fasciola hepatica); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). It is also used to control infections of D. viviparus and O. radiatum for 28 days after treatment and O. ostertagi, T. axei and C. punctata for 21 days after treatment, and H. placei and C. oncophora, for 14 days after treatment.
Dosage
1 milliliter (10 milligrams of ivermectin and 100 milligrams of clorsulon) per 50 kilograms (110 pounds). For subcutaneous use.
Limitations
For subcutaneous use only. Not for intravenous or intramuscular use. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Foals 2 Months And Older, Not For Food
Composition / specifications
Each milligram of paste contains 0.0155 milligram (1.55 percent) ivermectin and 0.0775 milligram (7.75 percent) praziquantel.
Horses
Indication
For treatment and control of the following parasites in horses: tapeworms--Anoplocephala perfoliata; large strongyles (adults)-- Strongylus vulgaris (also early forms in blood vessels), S. edentates (also tissue stages), S. equinus, Triodontophorus species including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; small strongyles (adults, including those resistant to some benzimidazole class compounds)--Coronocyclus species including C. coronatus, C. labiatus, and C. labratus, Cyathostomum species including C. catinatum and C. pateratum, Cylicocyclus species including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus species, Cylicostephanus species including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; small strongyles-fourth-stage larvae; pinworms (adults and fourth stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)--Parascaris equorum; hairworms (adults)--Trichostrongylus axei; large-mouth stomach worms (adults)--Habronema muscae; bots (oral and gastric stages)--Gasterophilus species including G. intestinalis and G. nasalis; lungworms (adults and fourth-stage larvae)--Dictyocaulus arnfieldi; intestinal threadworms (adults)--Strongyloides westeri; summer sores caused by Habronema and Draschia species cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca species.
Dosage

200 microgram per kilogram ivermectin (91 microgram per pound) and 1 milligram per kilogram praziquantel (454 micrograms per pound) body weight.

Limitations
For oral use only. Do not use in horses intended for human consumption. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
10 mg (1%) ivermectin and 100 mg (10%) clorsulon per mL
Label highlights
Indication

For the effective treatment and control of the following parasites in cattle:

Gastrointestinal Roundworms (adults and fourth-stage larve):
Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Oesophagostomum radiatum
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparous
Liver Flukes:
Fasciola hepatica (adults only)
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Manage Mites (Cattle Scab):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis

Persistent Activity
Ivermectin and clorsulon injection has been proven to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostronglyus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.

Dosage

1 mL for each 110 lbs (50 kg) body weight. This volume will deliver 10 mg ivermectin and 100 mg clorsulon.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Each milliliter (mL) of solution contains 1% (10 mg) w/v ivermectin and 10% (100 mg) w/v clorsulon.
Cattle
Indication

SparMectin Plus Clorsulon is indicated for the effective treatment and control of the following parasites of cattle:

Gastrointestinal Roundworms (adults and fourth-stage larvae):

Ostertagia ostertagi (including inhibited O. ostertagi)

O. lyrata

Haemonchus placei

Trichostrongylus axei

T. colubriformis

Cooperia oncophora

C. punctata

C. pectinata

Bunostomum phlebotomum

Nematodirus helvetianus (adults only)

N. spathiger (adults only)

Oesophagostomum radiatum

Lungworms (adults and fourth-stage larvae):

Dictyocaulus viviparus

Liver Flukes:

Fasciola hepatica (adults only)

Cattle Grubs (parasitic stages):

Hypoderma bovis

H. lineatum

Sucking Lice:

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Mange Mites: (cattle scab*):

Psoroptes ovis (syn. P. communis var. bovis)

Sarcoptes scabiei var. bovis

SparMectin Plus Clorsulon has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment.

Dosage

Administer 1 mL per 110 lb (50 kg) body weight. This delivers 10 mg ivermectin and 100 mg clorsulon.

Limitations

For subcutaneous use only. Not for intravenous or intramuscular use. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet contains either: 1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel; 2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel; 3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or 4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.
Dogs
Indication

For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms (Dipylidium caninum, Taenia pisiformis).

Dosage

Administer orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb), and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight, as follows:

  1. 6.0 to 12 pounds- one tablet containing 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel
  2. 12.1 to 25 pounds- one tablet containing 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel
  3. 25.1 to 50 pounds- one tablet containing 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel 
  4. 50.1 to 100 one tablet containing 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel
Limitations

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Bison, American • No use class stated or implied • Up to 70 pounds • Beef, excluding veal calves • Dairy, not breeding age • Reindeer, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of sterile aqueous solution contains 10 milligrams of ivermectin (1 percent).
Cattle, excluding veal calves
Indication
For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). To control infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.
Dosage
200 micrograms per kilogram of body weight.
Limitations
Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
Reindeer
Indication
It is used in reindeer for treatment and control of warbles (Oedemagena tarandi).
Dosage

200 micrograms per kilogram of body weight subcutaneously.

Limitations
For subcutaneous use only. Not for intramuscular use. Do not treat reindeer within 56 days of slaughter.
Swine
Indication
Used in swine for treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic larvae)); lungworms (Metastrongylus species (adults only)); lice (Haematopinus suis); and mites (Sarcoptes scabiei var. suis).
Dosage
300 micrograms per kilogram (2.2 pounds) subcutaneously.
Limitations
Do not treat swine within 18 days of slaughter.
American bison
Indication
It is used in American bison for the treatment and control of grubs (Hypoderma bovis).
Dosage
200 micrograms per kilogram (10 milligrams per 110 pounds) of body weight subcutaneously.
Limitations
For subcutaneous use. Do not slaughter within 56 days of last treatment.

FDA page: Open in Animal Drugs @ FDA

Species: Growing and finishing pigs up to 250 pounds
Composition / specifications
Type A medicated article containing 0.6 percent ivermectin. Type A medicated articles containing 20 or 50 grams per pound lincomycin.
Swine
Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults); lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis). Treatment of swine dysentery.

Dosage

1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) and 100 grams of lincomycin per ton of feed Type C medicated feed.

Limitations

Feed as the only feed for 7 consecutive days. Continue by feeding a separate feed containing 100 grams lincomycin/ton to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. This product is for use in swine only. This product should not be used for other animal species. Occasionally swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults);lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis). For reduction in severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.

Dosage

1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) and 200 grams of lincomycin per ton of Type C medicated feed.

Limitations

Feed as the only feed for 7 consecutive days. Follow by a separate feed containing 200 grams per ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. This product is for use in swine only. This product should not be used for other animal species. Occasionally swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum species, adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus species, adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For control of swine dysentery; for use in swine on premises with a history of swine dysentery, but where symptoms have not yet occurred.

Dosage

1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) and 40 grams of lincomycin per ton of Type C medicated feed.

Limitations

Feed as the only feed for 7 consecutive days. Continue by feeding a separate feed containing 40 grams lincomycin/ton to complete the lincomycin treatment. Withdraw 5 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. This product is for use in swine only. This product should not be used for other animal species. Occasionally swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
10 mg (1%) ivermectin and 100 mg (10%) clorsulon per mL
Cattle
Indication

For the effective treatment and control of the following parasites in cattle:

Gastrointestinal Roundworms (adults and fourth-stage larve):

  • Ostertagia ostertagi (including inhibited O. ostertagi)
  • O. lyrata
  • Haemonchus placei
  • Trichostrongylus axei
  • T. colubriformis
  • Cooperia oncophora
  • C. punctate
  • C. pectinate
  • Bunostomum phlebotomum
  • Nematodirus helvetianus (adults only)
  • N .spathiger (adults only)
  • Oesophagostomum radiatum

Lungworms (adults and fourth-stage larvae):


Dictyocaulus viviparous


Liver Flukes:


Fasciola hepatica (adults only)


Cattle Grubs (parasitic stages):


Hypoderma bovis
H. lineatum


Sucking Lice:

  • Linognathus vituli
  • Haematopinus eurysternus
  • Solenopotes capillatus
    Manage Mites (Cattle Scab):
    Psoroptes ovis (syn. P. communis var. bovis)


Persistent Activity
Ivermectin and clorsulon injection has been proven to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparous and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostronglyus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.

Dosage

1 mL for each 110 lbs (50 kg) body weight. This volume will deliver 10 mg ivermectin and 100 mg clorsulon.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Each milliliter of solution contains 5 milligrams of ivermectin
Cattle
Indication

For the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. surnabada, Oesophagostomum radiatum; (adults) Strongyloides papillosus, Trichuris spp. ; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Sarcoptes scabiei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; and horn flies Haematobia irritans. It controls infections and prevents reinfection with O. radiatum and D. viviparus for 28 days after treatment, C. punctata and T. axei for 21 days after treatment, H. placei, C. oncophora, Ostertagia ostertagi, and C. surnabada for 14 days after treatment, and D. bovis for 56 days after treatment.

Dosage
One milliliter per 22 pounds of body weight.
Limitations
Do not treat cattle within 48 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product on preruminating cales. Do not use on calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Paste contains 1.87 percent ivermectin.
Horses
Indication
For treatment and control of: Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults), Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri;Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
200 micrograms per kilogram (91 micrograms per pound) of body weight.
Limitations
For oral use only. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Adults • Breeding • Finishing • Growing • Sows with litters or about to farrow
Composition / specifications
Type A medicated article, contains 0.6% ivermectin
Type A medicated with 30, 50, 60 and 75 grams of bacitracin activity per pound
Weaned, Growing and Finishing Pigs
Indication
For increased rate of weight gain and improved feed efficiency in growing finishing swine.
Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 30 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Indication
For increased rate of weight gain and improved feed efficiency in growing and finishing swine.
Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 10 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Indication

For control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery but where signs of disease have not yet occurred; or following an approved treatment of the disease condition.

Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 250 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adult and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis).

Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 250 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adult and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis).

Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 10 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adult and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis).

Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 30 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Pregnant Sows
Indication
For control of clostridial enteritis caused by C. perfringens in suckling piglets.
Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 250 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

Indication

For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adult and fourth-stage larvae; Oesophagostomum spp., adult and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via colostrum or milk, when fed during gestation), lice (Haematopinus suis) and mange mites (Sarcoptes scabiei var. suis).

Dosage
Ivermectin: 1.8 g/ton Bacitracin methylene disalicylate: 250 g/ton
Limitations

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.This product contains IVOMEC brand ivermectin and has been formulated specifically for use in swine only. This product should not be used for other animal species. Do not permit water runoff from swine production sites to directly enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
Each mL of solution contains 5 mg of ivermectin.
Cattle
Indication

For the effective treatment and control of these parasites.

Gastrointestinal Roundworms- Ostertagia ostertagi (adults and L4) (including inhibited stage), Haemonchus placei (adults and L4), Trichostrongylus axei (adults and L4), T. colubriformis (adults and L4), Cooperia oncophora. (adults and L4), Cooperia punctata (adults and L4), Cooperia surnabada (adults and L4), Strongyloides papillosus (adults only), Oesophagostomum radiatum (adults and L4), and Trichuris spp. (adults only)

Lungworms- Dictyocaulus viviparus (adults and L4)

Cattle Grubs (parasitic stages)- Hypoderma bovis and H. lineatum

Mites- Sarcoptes scabiei var. bovis

Lice- Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, and Solenopotes capillatus

Horn Flies- Haematobia irritans

Persistent Activity- Privermectin® Pour-On for Cattle (ivermectin) has been proved to effectively control infections and to protect cattle from reinfection with:

Oesophagostomum radiatum and Dictyocaulus viviparus for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.

Treatment of Cattle for Horn Flies- Privermectin® Pour-On for Cattle (ivermectin) controls horn flies (Haematobia irritans) for up to 28 days after dosing.

Dosage

1 mL for each 22 lb of body weight (500 mcg/kg).

Limitations

Do not use on calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 10 milligrams of ivermectin
Horses
Indication

For the treatment and control of:

Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.”

Dosage
200 micrograms per kilogram of body weight as a single dose
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to us by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Paste contains 1.87 percent ivermectin.
Horses
Indication

For treatment and control of the parasites or parasitic conditions. Large Strongyles (adults)

Strongylus vulgaris

(also early forms in blood vessels),

S. edentatus

(also tissue stages),

S. equinus

,

Triodontophorus

spp. including

T. brevicauda

and

T. serratus

, and

Craterostomum acuticaudatum

;

Small Strongyles (adults, including those resistant to some benzimidazole class compounds) Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;

Small Strongyles Fourth-stage larvae;

Pinworms (adults and fourth-stage larvae) Oxyuris equi;

Ascarids (adults and third-and fourth-stage larvae) Parascaris equorum;

Hairworms (adults) Trichostrongylus axei;

Large-mouth Stomach Worms (adults) Habronema muscae;

Bots (oral and gastric stages) Gasterophilus spp. including G. intestinalis and G. nasalis;

Lungworms (adults and fourth-stage larvae) Dictyocaulus arnfieldi;

Intestinal Threadworms (adults) Strongyloides westeri;

Summer Sores caused by Habronema and Draschia spp. cutaneous third- stage larvae;

Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

Dosage

200 micrograms per kilogram (91 micrograms per pound) of body weight.

Limitations
For oral use only. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, No Use Class Stated Or Implied
Composition / specifications
Each gram of meal contains 6 milligrams ivermectin (0.6 percent).
Horses
Indication

For treatment and control of Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large Mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

Dosage
Administer 136 micrograms ivermectin per pound of body weight (300 micrograms per kilogram) as a single dose on approximately 2 pounds grain or sweet feed.
Limitations
Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
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Horses
Indication
For the treatment and control of Large strongyles (adults)--Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, and Triodontophorus spp. including T. brevicauda and T. serratus and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)--Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., and Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral and gastric stages)-- Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca.
Dosage
200 micrograms per kilogram (91 micrograms per pound) of body weight.
Limitations
For oral use only. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Bison, American • No use class stated or implied • No Use Class Stated Or Implied • No Use Class Stated Or Implied
Cattle, excluding veal calves
Indication
For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). To control infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment
Dosage
200 micrograms per kilogram of body weight
Limitations
Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Not for intravenous or intramuscular use. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Dose by subcutaneous injection.
Reindeer
Indication
It is used in reindeer for treatment and control of warbles (Oedemagena tarandi).
Dosage
200 micrograms per kilogram (10 milligrams per 110 pounds) body weight subcutaneously.
Limitations
For subcutaneous use only. Not for intramuscular use. Do not treat reindeer within 56 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Swine
Indication
Used in swine for treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic larvae)); lungworms (Metastrongylus species (adults only)); lice (Haematopinus suis); and mites (Sarcoptes scabiei var. suis).
Dosage
300 micrograms per kilogram (2.2 pounds) subcutaneously.
Limitations
For subcutaneous injection in the neck of swine only. Do not treat swine within 18 days of slaughter. Do not use in other animal species as severe adverse reactions including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism
American bison
Indication
It is used in Amer ican bison for the treatment and control of grubs (Hypoderma bovis).
Dosage
200 micrograms per kilogram (10 milligrams per 110 pounds) of body weight subcutaneously.
Limitations
For subcutaneous use. Do not slaughter within 56 days of last treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Excluding Under 6 Weeks Age
Composition / specifications
Each chewable contains 68, 136, or 272 micrograms of ivermectin.
Dogs
Indication
To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection.
Dosage
6.0 micrograms per kilogram body weight (2.72 micrograms per pound), minimum. up to 25 pounds, 68 micrograms; 26 to 50 pounds 136 micrograms; 51 to 100 pounds, 272 micrograms; 100 pounds, a combination of the appropriate tablets.
Limitations
Use once-a-month. Recommended for dogs 6 weeks of age and older. Initial use within 1 month after first exposure to mosquitoes. Final use within 1 month after last exposure to mosquitoes. All dogs should be tested for existing heartworm infection before starting treatment with HEARGARD which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae prior to initiating a program with HEARGARD. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Fox, Ranch • Bison, American • No use class stated or implied • Up to 70 pounds • Beef, excluding veal calves • Dairy, not breeding age • Reindeer, No Use Class Stated Or Implied
Composition / specifications
Cattle, swine, and reindeer: each milliliter of sterile aqueous solution contains 10 milligrams of ivermectin (1 percent). Piglets 70 pounds or less and ranch-raised foxes: each milliliter of sterile aqueous solution contains 2.7 milligrams of ivermectin (0.27 percent).
Cattle, excluding veal calves
Indication
For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). To control infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.
Dosage
200 micrograms per kilogram of body weight.
Limitations
Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Not for intravenous or intramuscular use. Do not use in other animal species because severe adverse reactions, including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Dose by subcutaneous injection.
Reindeer
Indication
It is used in reindeer for treatment and control of warbles (Oedemagena tarandi.
Dosage
1 milliliter per 50 kilograms (110 ponds) body weight subcutaneously.
Limitations
For subcutaneous use only. Not for intramuscular use. Do not treat reindeer within 56 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Swine
Indication
Used in swine for treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic larvae)); lungworms (Metastrongylus species (adults only)); lice (Haematopinus suis); and mites (Sarcoptes scabiei var. suis).
Dosage
300 micrograms per kilogram (2.2 pounds) subcutaneously.
Limitations
For subcutaneous injection in the neck of swine only. Do not treat swine within 18 days of slaughter. Do not use in other animal species as severe adverse reactions including fatalities in dogs, may result. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
Ranch-raised foxes
Indication
For treatment and control of ear mites (Otodectes cynotis).
Dosage
200 micrograms per kilogram body weight subcutaneously. Repeat in 3 weeks.
Limitations
For subcutaneous use only. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
American bison
Indication
It is used in American bison for the treatment and control of grubs (Hypoderma bovis).
Dosage
200 micrograms per kilogram (10 milligrams per 110 pounds) of body weight subcutaneously.
Limitations
For subcutaneous use. Do not slaughter within 56 days of last treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

FDA page: Open in Animal Drugs @ FDA

Species: Adults • Breeding • Finishing • Growing
Composition / specifications
Type A medicated articles: 0.6 percent (2.72 grams per pound; 6 grams per kilogram)
Swine (Growing-Finishing)
Indication
For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum species, adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus species, adults), lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).
Dosage
1.8 grams of ivermectin per ton. Feed to provide 0.1 milligram per kilogram of body weight per day.
Limitations
Feed as the only feed for 7 consecutive days. For use in swine only. Withdraw 5 days before slaughter.
Swine (Mature and Breeding)
Indication
For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum species, adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus species, adults), lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis).
Dosage
1.8 to 11.8 grams of ivermectin per ton or 18.2 to 120 grams of ivermectin per ton as a top-dress on the daily feed ration (to provide 0.1 milligram per kilogram of body weight per day.
Limitations
Feed as the only feed for 7 consecutive days. For use in swine only. Withdraw 5 days before slaughter. in liquid feed supplements.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Paste contains 1.87 percent ivermectin
Horses
Indication
For treatment and control of: Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults), Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri;Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
200 micrograms per kilogram (91 micrograms per pound) of body weight.
Limitations
For oral use only. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, No Use Class Stated Or Implied
Composition / specifications
Each milligram of paste contains 0.0187 mg (1.87 percent) ivermectin and 0.1403 mg (14.03 percent) praziquantel.
Horses
Indication
For treatment and control of the following parasites in horses: Tapeworms--Anoplocephala perfoliata; Large Strongyles (adults)--Strongylus vulgaris (also early forms in blood vessels), S.edentatus (also tissue stages), S. equinus, Triodontophorus spp.; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)--Cyathostomum species, Cylicocyclus species, Cylicostephanus species, Cylicodontophorus species; Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral and gastric stages)--Gasterophilus species; Lungworms (adults and fourth-stage larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca species.
Dosage
200 microgram per kilogram ivermectin (91 microgram per pound) and 1.5 milligram per kilogram praziquantel (.68 milligram per pound) body weight.
Limitations
For oral use in horses only. Do not use in horses intended for human consumption. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, not breeding age
Composition / specifications
Each milliliter of solution contains 5 milligrams of ivermectin.
Cattle
Indication
It is used topically for the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia (Cooperia oncophora , C. punctata , C. surnabada), Oesophagostomum radiatum; (adults) O. venulosum, Strongyloides papillosus, Trichuris species; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Chorioptes bovis, Sarcoptes scabei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; horn flies Haematobia irritans. It is also used to control infections of gastrointestinal roundworms O. ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Dosage
One milliliter per 22 pounds of body weight.
Limitations
Do not treat cattle within 48 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Bison, American • No use class stated or implied • Beef And Dairy • No Use Class Stated Or Implied
Composition / specifications
<span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each mL contains 10 mg of ivermectin.</span>
American bison
Indication
For the treatment and control of grubs (Hypoderma bovis).
Dosage
200 micrograms ivermectin per kilogram  of body weight subcutaneously.
Limitations
For subcutaneous use only.
Reindeer
Indication
For treatment and control of warbles (Oedemagena tarandi).
Dosage
200 micrograms ivermectin per kg body weight subcutaneously.
Limitations
For subcutaneous use only.
Swine
Indication
For treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum species; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, Strongyloides ransomi (somatic larvae)); lungworms (Metastrongylus species (adults only)); lice (Haematopinus suis); and mangemites (Sarcoptes scabiei var. suis).
Dosage
1 mL per 75 lb (300 micrograms ivermectin per kilogram) body weight subcutaneously.
Limitations
For subcutaneous use in the neck only.
Cattle
Indication
For the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis).

Persistent activity:
For control of infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi , T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.

Dosage
1 mL per 110 lb (200 micrograms ivermectin per kilogram) body weight subcutaneously .
Limitations
Do not use in calves to be processed for veal. For subcutaneous use only.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
<span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA; mso-bidi-font-family: 'Times New Roman'">Each milliliter contains 10 milligrams of ivermectin.</span>
Horses
Indication
For treatment and control of large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages):Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults), Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
200 micrograms per kilogram of body weight as a single dose.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to us by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Cat And Kitten, Excluding Under 4 Weeks Of Age
Composition / specifications
Each tube contains 0.5 milliliter of a 0.01 percent suspension of ivermectin.
Cats and Kittens (4 Weeks of Age and Older)
Indication
For the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.
Dosage
Administer the contents of one 0.5-milliliter tube topically into each external ear canal.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
The product is available in unit applicator tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters. Each milliliter of solution contains 100 milligrams imidacloprid and 800 micrograms ivermectin.
Dogs
Indication
For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis).
Dosage
The recommended minimum dosage is 4.5 milligram per pound (10 milligram per kilogram) of imidacloprid and 36.4 micrograms per pound (80 micrograms per kilogram) of ivermectin, topically once a month.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Paste contains 1.87 percent ivermectin.
Horses
Indication
For treatment and control of: Large strongyles (adults)--Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, and Triodontophorus spp. including T. brevicauda and T. serratus; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)-- Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., and Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-stage larvae)-- Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)-- Parascaris equorum; Hairworms (adults)-- Trichostrongylus axei; Large-mouth Stomach Worms (adults)-- Habronema muscae; Bots (oral and gastric stages)-- Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)-- Dictyocaulus arnfieldi; Intestinal Threadworms (adults)-- Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Dosage
200 micrograms per kilogram (91 micrograms per pound) of body weight.
Limitations
For oral use only. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Cats and kittens, excluding kittens under 6 weeks age
Composition / specifications
Each chewable contains 55 or 165 micrograms of ivermectin.
Cats (6 Weeks of Age and Older)
Indication
To prevent feline heartworm disease by eliminating the tissue stage of heartworm larvae Dirofilaria immitis for a month (30 days) after infection, and for removal and control of adult and immature (L4) hookworms Ancylostoma tubaeforme and A. braziliense.
Dosage
Up to 2.3 kilograms (up to 5 pounds), 55 micrograms; 2.3 - 6.8 kilograms (5 to 15 pounds), 165 micrograms; over 6.8 kilograms (15 pounds), a combination of appropriate chewables (recommended minimum dose of 24 micrograms of ivermectin per kilogram of body weight (10.9 micrograms per pound).
Limitations
For use in cats 6 weeks of age and older. Administer once a month. The initial dose must be given within a month after cats first exposure to mosquitoes. The final dose must be given within a month after the cats last exposure to mosquitoes.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Excluding Under 6 Weeks Age
Composition / specifications
Each chewable tablet contains either 68 micrograms of ivermectin and 57 milligrams of pyrantel (as pamoate salt), or 136 micrograms ivermectin and 114 milligrams pyrantel, or 272 micrograms and 227 milligrams, respectively.
Dogs
Indication
To prevent canine heartworm diseases by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection. For the treatment and control of ascarids (Toxocara canis, Toxascaris leonine), and hookworms (Ancylostoma caninum, A braziliense, and Uncinaria stenocephala).
Dosage
A minimum of 6 micrograms of ivermectin and 5 milligrams of pyrantel (as pamoate salt) per kilogram (2.72 micrograms and 2.27 milligrams per pound) of body weight. up to 25 pounds: 68 micrograms ivermectin and 57 milligrams pyrantel pamoate 26 to 50 pounds: 136 micrograms ivermectin and 114 milligrams pyrantel pamoate 51 to 100 pounds: 272 micrograms ivermectin and 227 milligrams pyrantel pamoate
Limitations
Use monthly. Recommended for dogs 6 weeks of age or older. Federal law restricts this drug to use by or on the order of a veterinarian. All dogs should be tested for existing heartworm infection before starting treatment with HEARTGARD Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult heartworms and microfilariae before initiating a program with HEARTGARD Plus.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Excluding Under 6 Weeks Age
Composition / specifications
Each tablet or cube contains 68 micrograms of ivermectin.
Dogs
Indication
To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection.
Dosage
6.0 micrograms per kilogram body weight (2.72 micrograms per pound), minimum. up to 25 pounds, 68 micrograms; 26 to 50 pounds 136 micrograms; 51 to 100 pounds, 272 micrograms; over 100 pounds, a combination of the appropriate tablets. The drug is administered at monthly dosing intervals.
Limitations
Use once-a-month. Recommended for dogs 6 weeks of age and older. Initial use within 1 month after first exposure to mosquitoes. Final use within 1 month after last exposure to mosquitoes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each chewable tablet contains:
(1) 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel;
(2) 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel;
(3) 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel; or
(4) 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel.
Dogs (12.1 - 25 Lbs)
Indication
Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonine), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.
Dosage
Administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight. (One table monthly containing 68 mcg ivermectin, 57 mg pyrantel pamoate, and 57 mg praziquantel)
Limitations
For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs (6.0 - 12 Lbs)
Indication
Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonine), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.
Dosage
Administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight. (One tablet monthly containing 34 micrograms (mcg) ivermectin, 28.5 milligrams (mg) pyrantel pamoate, and 28.5 mg praziquantel)
Limitations
For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs (50.1 - 100 Lbs)
Indication
Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonine), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.
Dosage
Administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight. (One tablet monthly containing 272 mcg ivermectin, 228 mg pyrantel pamoate, and 228 mg praziquantel)
Limitations
For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Dogs (25.1 - 50 Lbs)
Indication
Prevents canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonine), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworm (Dipylidium caninum, Taenia pisiformis) infections.
Dosage
Administered orally at monthly intervals at the recommended minimum dose level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb), 5 mg of pyrantel (as pamoate salt) per kg (2.27 mg/lb) and 5 mg of praziquantel per kg (2.27 mg/lb) of body weight. (One tablet monthly containing 136 mcg ivermectin, 114 mg pyrantel pamoate, and 114 mg praziquantel)
Limitations
For oral use in dogs only. IVERHART MAX Chewable Tablets are recommended for dogs 8 weeks of age and older. For dogs over 100 lbs, use the appropriate combination of these Chewable Tablets. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each tablet or cube contains 68 micrograms of ivermectin.
Dogs
Indication
To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection.
Dosage
6.0 micrograms per kilogram body weight (2.72 micrograms per pound), minimum. up to 25 pounds, 68 micrograms; 26 to 50 pounds 136 micrograms; 51 to 100 pounds, 272 micrograms; over 100 pounds, a combination of the appropriate tablets. The drug is administered at monthly dosing intervals
Limitations
Use once-a-month. Recommended for dogs 6 weeks of age and older. Initial use within 1 month after first exposure to mosquitoes. Final use within 1 month after last exposure to mosquitoes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each cube contains 68, 136, or 272 micrograms of ivermectin.
Dogs
Indication
To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection.
Dosage
6.0 micrograms per kilogram body weight (2.72 micrograms per pound), minimum. up to 25 pounds, 68 micrograms; 26 to 50 pounds, 136 micrograms; 51 to 100 pounds, 272 micrograms; 100 pounds, a combination of the appropriate tablets. The drug is administered at monthly dosing intervals.
Limitations
Use once-a-month. Recommended for dogs 6 weeks of age and older. Initial use within 1 month after first exposure to mosquitoes. Final use within 1 month after last exposure to mosquitoes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Bison, American • No use class stated or implied • Beef, excluding veal calves • Dairy, not breeding age • No Use Class Stated Or Implied
Composition / specifications
<span style="font-size: 10pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA"><span style="font-size: 10.5pt; font-family: Verdana; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: 'Times New Roman'; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA">Each milliliter (mL) of solution contains 10 milligrams (mg) ivermectin.</span></span>
Cattle (excluding veal calves)
Indication
For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). For control of infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.

Limitations: Do not use in calves to be processed for veal.

Dosage
200 micrograms ivermectin per kilogram of body weight (1 mL per 50 kg of body weight).
Limitations
Do not use in calves to be processed for veal.
Reindeer
Indication
For the treatment and control of warbles (Oedemagena tarandi).
Dosage
200 micrograms ivermectin per kilogram of body weight (1 mL per 50 kg of body weight).
Limitations
Bison (American bison)
Indication
For the treatment and control of grubs (Hypoderma bovis).
Dosage
200 micrograms ivermectin per kilogram of body weight (1 mL per 50 kg of body weight).
Limitations
Swine
Indication
For the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi (adults only)); somatic roundworm larvae (threadworm, S. ransomi (somatic larvae)); lungworms (Metastrongylus spp. (adults only)); lice (H. suis); and mites (S. scabiei var. suis).
Dosage
300 micrograms ivermectin per kilogram of body weight (1 mL per 33 kg of body weight).
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, not breeding age
Composition / specifications
Paste contains 0.153 percent ivermectin.
Cattle
Indication
It is used in cattle for the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (first, second and third instars) (Hypoderma bovis, H. lineatum); and sucking lice (Linognathus vituli, Haematopinus eurysternus).
Dosage
23 milligrams per 250 pounds of body weight.
Limitations
For oral use only. Do not treat cattle within 24 days of slaughter. Because withdrawal time in milk has not been established, do not use in female dairy of breeding age. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Calves 3 months and older • Dairy, not breeding age
Composition / specifications
Each sustained-release bolus contains 1.72 grams of ivermectin.
Cattle (Calves, Ruminating)
Indication
For treatment and control, throughout the grazing season (approximately 130 days), of gastrointestinal roundworms Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia species, Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum radiatum; lungworms Dictyocaulus viviparous; grub Hypoderma species; sucking lice Linognathus vituli, Solenopotes capillatus; mange mites Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum.
Dosage
Administer one bolus per calf weighing at least 275 pounds (125 kilograms) and not more than 660 pound (300 kilograms) on the day of administration.
Limitations
The bolus was specifically designed for use in cattle. Do not use in other animal species. Calves must be ruminating and older than 12 weeks of age. Do not administer to calves weighing less than 275 pounds (125 kilograms). Do not administer a damaged bolus. Because a milk withdrawal time has not been established, do not use in female dairy cattle of breeding age. Do not slaughter within 180 days of treatment. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Not For Meat Production
Composition / specifications
Each milliliter contains 10 milligrams of ivermectin.
Horses
Indication
Large Strongyles (Strongylus equinus (adult), S. vulgaris (adult and arterial larval stages), S. endentatus (adult and migrating tissue stages), Triodontophorus spp. (adult)); Small Strongyles including those resistant to some benzimidazole class compounds (Cyathostomum spp. (adult and fourth-stage larvae), Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); Pinworms (Oxyuris equi (adult and fourth-stage larvae)); Ascarids (Parascaris equorum (adult and third- and fourth-stage larvae)); Hairworms (Trichostongylus axei (adult)); Large mouth Stomach Worms (Habronema muscae (adult)); Stomach Bots (Gastrophilus spp. (oral and gastric stages)); Lungworms (Dictyocaulus arnfieldi (adult and fourth-stage larvae)); intestinal threadworms (Strongyloides westeri (adult)); Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; and Dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).
Dosage
200 micrograms per kilogram of body weight as a single dose.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to us by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Sheep, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 10 milligrams ivermectin.
Sheep
Indication
For treatment and control of the adult and fourth-stage larvae of the following gastrointestinal roundworms - Haemonchus contortus, H. placei (adults only), Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults only), C. curticei, Oesophagostomum columbianum, O. venulosum (adults only), Nematodirus battus, N. spathiger, S. papillosus (adults only), Chabertia ovina (adult only), Trichuris ovis (adults only); lungworms (D. filaria); and all larval stages of the nasal bot Oestrus ovis.
Dosage
200 micrograms per kilogram (3 milliliter per 26 pounds) of body weight as a single dose oral drench.
Limitations
For use in sheep only. Do not use in other animal species as severe adverse reactions, including fatalities in dogs, may result. Do not treat sheep within 11 days of slaughter.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary
    This supplement is to decrease the withdrawal period from 49 days to 21 days.
  • Summary
    To extend the persistent effect periods for Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information and to add the veal calf warning statement to the residue information section.
  • Summary

    Extend the period of persistent activity against Dictyocaulus viviparus from 21 days to 28 days after treatment.

  • Summary

    New claims for persistent control of gastrointestinal roundworms and lungworms.

  • Summary
    Ivomec-F Injection For Cattle is indicated for the treatment and control of the following species of gastrointestinal nematodes, lungworms, liver flukes, grubs, sucking lice, and mange mites of cattle.
SPL Packages

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Documents
  • Summary
    For the control of certain gastrointestinal nematodes, lungworms, and nasal bots in sheep.
  • EA 131-392
  • FONSI 131-392
SPL Packages

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Documents
  • Summary

    For the treatment and control of the following parasites in horses over 5 months of age: TapewormsAnoplocephala perfoliata; Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp. Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum; Small Strongyles - Fourth-stage larvae; Pinworms (adults and fourth-stage larvae)- Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

SPL Packages

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Documents
  • Summary
    Prevents heartworm disease by eliminating the tissue stage of heartworm (Dirofilaria immitis) larvae for a month after infection and for the treatment and control of ascarids (Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).
SPL Packages

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Documents
  • Summary
    For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, large-mouth stomach worms, bots, lungworms, summer sores and cutaneous onchocerciasis.
SPL Packages

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Documents
  • Summary
    To add the new persistent activity indications for Dictyocaulus viviparus for 28 days after treatment, Cooperia surnabada for 14 days after treatment, and Damalinia bovis for 56 days after treatment. To extend the persistent activity periods for Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 days to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information, to speciate Cooperia spp in the treatment and control section of the indications, and to add the veal calf warning statement to the residue information section.
  • Summary

    New claims for persistent control of gastrointestinal roundworms

  • Summary

    For the treatment and control of gastrointestinal nematodes (including inhibited immature Ostertagia ostertagi); lungworms (Dictyocaulus viviparus); cattle grubs (Hypoderma spp.); sucking and biting lice; sarcoptic mange mites. The following species are included:

    Gastrointestinal roundworms: Ostertagia ostertagi(adults and L4, including inhibited), Haemonchus placei(adults and L4), Trichostrongylus axei(adults and L4), T. colubriformis(adults and L4), Cooperia spp. (adults and L4), Strongyloides papillosus(adults), Oesophagostomum radiatum(adults and L4), Trichuris spp. (adults)

    Lungworms: Dictyocaulus viviparus (adults and L4)

    Cattle grubs (parasitic stages): Hypoderma bovis, H. lineatum

    Lice: Linognathus vituli, Haematopinus eurysternus, Damalina bovis, Solenopotes capillatus

    Mites: Sarcoptes scabiei var bovis.

    Flies: Hematobia irritans(adults).

  • EA 140-841
  • FONSI 140-841
  • EA 140-841
  • FONSI 140-841
SPL Packages

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SPL Packages

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Documents
  • Summary
    This supplement amends the EQVALAN (ivermectin) Oral Liquid For Horses labeling to add four species of internal parasites and to reflect a change in the Indications section which separates the listing of adult small strongyle species from their related fourth-stage larvae. Specifically, the supplement provides for the use of ivermectin oral liquid for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp. including Coronocyclus coronatus and Coronocyclus labratus. In addition, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from their related fourth-stage larvae.
  • Summary

    For treatment and control of the following parasites or parasitic conditions in horses: bots, large mouth stomach worms, neck threadworms, pinworms, ascarids, lungworms, intestinal threadworms, small strongyles large strongyles, summer sores, and dermatitis caused by neck threadworm microfilariae.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Ivermectin (ivermectin) Paste 1.87% provides effective treatment and control of the following parasites in horses:

    Large Strongyles (adults) - Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum;
    • Small Strongyles (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum;
    • Small Strongyles - Fourth-stage larvae;
    • Pinworms (adults and fourth-stage larvae) - Oxyuris equi;
    • Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum;
    • Hairworms (adults) - Trichostrongylus axei;
    • Large-mouth Stomach Worms (adults) - Habronema muscae;
    • Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis;
    • Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi;
    • Intestinal Threadworms (adults) - Strongyloides westeri;
    • Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
    • Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    NOROMECTIN Plus Injection for Cattle is indicated for the effective treatment and control of the following parasites in cattle:  Gastrointestinal Roundworms (adults and fourth-stage larvae):
    Ostertagia ostertagi (including inhibited O. ostertagi)
    O. lyrata
    Haemonchus placei
    Trichostrongylus axei
    T. colubriformis
    Cooperia oncophora
    C. punctata
    C. pectinata
    Bunostomum phlebotomum
    Nematodirus helvetianus     (adults only)
    N. spathiger (adults only)
    Oesophagostomum radiatum
    Lungworms (adults and fourth-stage larvae):
    Dictyocaulus viviparus
    Liver Flukes:
    Fasciola hepatica (adults only)
    Cattle Grubs (parasitic stages):
    Hypoderma bovis
    H. lineatum
    Sucking Lice:
    Linognathus vituli
    Haematopinus eurysternus
    Solenopotes capillatus
    Mange Mites (cattle scab):
    Psoroptes ovis (syn. P. communis var. bovis)
    Sarcoptes scabiei var. bovis
    Persistent Activity
    Ivermectin and clorsulon injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei, Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.

SPL Packages

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Documents
  • Summary
    This supplement amends the ZIMECTERIN Gold (ivermectin/praziquantel) Paste labeling to reflect the change in the age of treatment from “5 months of age and older” to “2 months of age and older.”
  • Summary
    This supplement amends the ZIMECTRIN Gold (ivermectin/praziquantel) Paste labeling to reflect a change in the indications section. Specifically, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. The label language has also been revised for treatment frequency; removing the eight week intertreatment interval because treatment frequency should be based on a parasite control program designed specifically for each horse. A new precaution statement has also been added.
  • Summary

    For treatment and control of the following parasites in horses: Tapeworms: noplocephala perfoliata Large strongyles (adults):
    Strongylus vulgaris (also early forms in blood vessels), Strongylus edentatus (also tissue stages), Strongylus equinus Triodontophorus spp. including: Triodontophorus brevicauda, Triodontophorus serratus,
    Craterostomum acuticaudatum     Small strongyles: Including those resistant to some benzimidazole class compounds (adults and 4th stage larvae)
    Coronocyclus spp. including: Coronocyclus coronatus, Coronocyclus labiatus, Coronocyclus labratus, Cyathostomum spp. including:
    Cyathostomum catinatum, Cyathostomum pateratum, Cylicocyclus spp. including: Cylicocyclus insigne, Cylicocyclus leptostomum, Cylicocyclus nassatus, Cylicocyclus brevicapsulatus, Cylicodontophorus spp.
    Cylicostephanus spp. including: Cylicostephanus calicatus, Cylicostephanus goldi, Cylicostephanus longibursatus, Cylicostephanus minutus Petrovinema poculatum Pinworms (adults and 4th stage larvae) - Oxyuris equi Ascarids (adults and 3rd and 4th stage larvae) - Parascaris equorum Hairworms (adults) - Trichostrongylus axei Large-mouth stomach worms (adults) - Habronema muscae Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis
    Lungworms (adults and 4th stage larvae) - Dictyocaulus arnfieldi
    Intestinal threadworms (adults) - Strongyloides westeri Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; dermatitis caused by neck threadworm microfilariae, Onchocerca

SPL Packages

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Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for a decrease in the residue withdrawal period for cattle from 49 days to 21 days prior to slaughter.

  • Summary

    SparMectin Plus Clorsulon is indicated for the effective treatment and control of the following parasites of cattle:
    Ostertagia ostertagi (including inhibited O. ostertagi)
    O. lyrata
    Haemonchus placei
    Trichostrongylus axei
    T. colubriformis
    Cooperia oncophora
    C. punctata
    C. pectinata
    Bunostomum phlebotomum
    Nematodirus helvetianus     (adults only)
    N. spathiger (adults only)
    Oesophagostomum radiatum
    Lungworms (adults and fourth-stage larvae):
    Dictyocaulus viviparus
    Liver Flukes:
    Fasciola hepatica (adults only)
    Cattle Grubs (parasitic stages):
    Hypoderma bovis
    H. lineatum.
    Sucking Lice:
    Linognathus vituli
    Haematopinus eurysternus
    Solenopotes capillatus
    Mange Mites: (cattle scab*):
    Psoroptes ovis (syn. P. communis var. bovis)
    Sarcoptes scabiei var. bovis
    SparMectin Plus Clorsulon has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment; Haemonchus placei, and Cooperia oncophora for 14 days after treatment.

SPL Packages

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Documents
  • Summary

    For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworms (Dipylidium caninum, Taenia pisiformis).

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for extension of persistent effect indications as claimed by thepioneer sponsor. Specifically, the package insert has been revised as follows: Persistent activity against Oesophagostomum radiatumchanged from 14 to 28 days and that of Trichostrongylus axei and Cooperia punctatafrom 14 to 21 days.
  • Summary

    Cattle: NOROMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle:
    Gastrointestinal Roundworms (adults and fourth-stage larvae):
    Ostertagia ostertagi (including inhibited O. ostertagi)
    O. lyrata
    Haemonchus placei
    Trichostrongylus axei
    T. colubriformis
    Cooperia oncophora
    C. punctata
    C. pectinata
    Oesophagostomum radiatum
    Bunostomum phlebotomum
    Nematodirus helvetianus (adults only)
    N. spathiger (adults only)
    Lungworms (adults and fourth-stage larvae):
    Dictyocaulus viviparus
    Cattle Grubs (parasitic stages):
    Hypoderma bovis
    H. lineatum
    Sucking Lice:
    Linognathus vituli
    Haematopinus eurysternus
    Solenopotes capillatus
    Mites (scabies):
    Psoroptes ovis     (syn. P. communis var. bovis)
    Sarcoptes scabiei var. bovis
    Persistent Activity
    Ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus for 28 days after treatment; Ostertagia ostertagi for 21 days after treatment; Oesophagostomum radiatum, Haemonchus placei, Trichostrongylus axei, Cooperia punctata and Cooperia oncophora for 14 days after treatment.
    Swine: NOROMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine:
    Gastrointestinal Roundworms:
    Large roundworm, Ascaris suum
    (adults and fourth-stage larvae)
    Red stomach worm, Hyostrongylus rubidus
    (adults and fourth-stage larvae)
    Nodular worm, Oesophagostomum spp.
    (adults and fourth-stage larvae)
    Threadworm, Strongyloides ransomi (adults)
    Somatic Roundworm Larvae:
    Threadworm, Strongyloides ransomi (somatic larvae). Sows must be treated at least seven days before farrowing to prevent infection in piglets.
    Lungworms:
    Metastrongylus spp.(adults)
    Lice:
    Haematopinus suis
    Mange mites:
    Sarcoptes scabiei var. suis
    Special Minor Use:
    NOROMECTIN Injection is indicated for the effective treatment and control of warbles (Oedemagena tarandi) in reindeer. Follow use directions for cattle as described under Administration
    NOROMECTIN Injection is indicated for the effective treatment and control of grubs (Hypoderma bovis) in American bison. Follow use directions for cattle as described under Administration.

SPL Packages

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Documents
  • Summary
    Ivermectin: For the treatment and control of gastrointestinal roundworms, kidneyworms, lungworms, lice and mange mites in swine. Lincomycin: for increased rate of weight gain, for treatment and control of swine dysentery, and for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae in swine.
SPL Packages

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Documents
SPL Packages

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Documents
  • Summary
    The effect of the supplement is to add claims that are no longer protected by three years marketing exclusivity that expired on November 24, 2006, specifically: Dictyocaulus viviparus for 28 days, Cooperia surnabada for 14 days, and Damalinia bovis for 56 days after treatment. Also, the persistent activity periods are extended for the following: Oesophagostomum radiatum from 14 days to 28 days and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment.
  • Summary
    NOROMECTIN (ivermectin) Pour-On for Cattle when applied at the recommended dose of 500 mcg/kg is indicated for the effective control and treatment of gastrointestinal roundworms (including Ostertagia ostertagi) lungworms, grubs, hornflies, sucking and biting lice, and sarcoptic mange mites in cattle.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement amends the EQVALAN (ivermectin) Paste 1.87% labeling to reflect a change in the indications section. Specifically, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from the fourth -stage larvae.
  • Summary
    The supplement provides for the use of ivermectin paste for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp. including: Coronocyclus coronatus, and Coronocyclus labratus. Also, the label descriptions of some currently-approved parasite genera are being revised to add included species for which data already exists in the NADA file and to reflect changes in scientific nomenclature.
SPL Packages

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Documents
  • Summary
    For the treatment and control of gastrointestinal roundworms ( Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms ( Stephanurus dentatus, adults and fourth-stage larvae), lungworms ( Metastrongylus spp., adults), threadworms ( Strongyloides ransomi, adults and somatic larvae and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation), lice ( Haematopinus suis), and mange mites ( Sarcoptes scabiei var. suis).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For adding the Material Safety Data Sheet (MSDS) information, removing the black box around the residue warning statement, adding the statement “Restricted Drug (California)-Use Only as Directed,” and adding the following under the persistent activity section:  “PRIVERMECTIN Pour-On has been proved to effectively control infections and to protect cattle from reinfection with:  Oesophagostomum radiatum and Dictyocaulus viviparus for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment;  Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.”
  • Summary
    Treatment and control of gastrointestinal roundworms, lungworms, mites, cattle grubs, lice, and horn flies.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for a change in preservative from benzyl alcohol to a combination of methylparaben and propylparaben, and a change in manufacturing process. In addition, product indications were updated to be consistent with the most recently approved labeling for the reference listed new animal drug (RLNAD).

  • Summary
    For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, largemouth stomach worms, bots, lungworms and summer sores. Also treats cutaneous onchocerciasis.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement requests the addition of labeling claims that are no longer protected by marketing exclusivity for the following parasite species: Craterostomum acuticaudatum, Coronocyclus coronatus, Coronocyclus labratus and Petrovinema poculatum.

  • Summary
    For treatment and control of the parasites or parasitic conditions. Large strongyles (adults): S. vulgaris (and arterial larval stages), S. edentatus (and tissue stages), S. equinus, Triodontophorus spp.; Small strongyles (adults and fourth-stage larvae) including those resistant to some benzimidizole class compounds: Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large-mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gastrophilus spp.; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca spp.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For treatment and control of the following parasites in horses: Large strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda, and T. serratus and Craterostomum acuticaudatum; Small strongyles: (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including: C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including: C. catinatum, C. pateratum, Cylicocyclus spp. including: C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including: C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles – Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) - Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouthStomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for new indications for use claims no longer protected by a three-year exclusivity period that expired on April 2, 2006:   Large Strongyles – Craterostomum acuticaudatum; Small Strongyles – Petrovinema poculatum and Coronocyclus spp. including C. coronatus, and C. labratus. The generic labeling includes an additional indication for use claim for a parasite species not protected by exclusivity, C. labiatus.  This supplement also provides for revised packaging and minor label revisions.
  • Summary

    BIMECTIN Paste 1.87% provides effective treatment and control of the following parasites in horses: Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S .edentatus (also tissue stages), S. equinus; Triodontophorus spp. including T. brevicauda and T. serratus; Small Strongyles (adults, including those resistant to some benzimidizole class compounds) – Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Small Stronglyes – Fourth-stage larvae; Pinworms (adults and fourthstage larvae) – Oxyuris equi; Ascarids (adults, thirdstage and fourth-stage larvae) Parascaris equorum; Hairworms (adults):
    Trichostrongylus axei; Large-mouth Stomach Worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stages larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca spp.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle: Bimectin® Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle:
    Gastrointestinal Roundworms (adults and fourth-stage larvae): Ostertagia ostertagi (including inhibited O. ostertagi), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctataC. pectinata, Oesophagostomum radiatum, Bunostomum phlebotomum, Nematodirus helvetianus (adults only), N. spathiger (adults only)
    Lungworms (adults and fourth-stage larvae): Dictyocaulus viviparus
    Cattle Grubs (parasitic stages): Hypoderma bovis, H. lineatum
    Sucking Lice: Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus
    Mites (scabies): Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis.
    Persistent Activity
    Ivermectin Injection has been proven to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei, and Cooperia punctata for 21 days after treatment; and Haemonchus placei and Cooperia oncophora for 14 days after treatment.
    Swine: Bimectin® Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine:
    Gastrointestinal Roundworms:
    Large roundworm, Ascaris suum (adults and fourth-stage larvae)
    Red stomach worm, Hyostrongylus rubidus (adults and fourth-stage larvae)
    Nodular worm, Oesophagostomum spp. (adults and fourth-stage larvae)
    Threadworm, Strongyloides ransomi (adults)
    Somatic Roundworm Larvae:
    Threadworm, Strongyloides ransomi (somatic larvae)
    Sows must be treated at least seven days before furrowing to prevent infection in piglets.
    Lungworms: Metastrongylus spp. (adults)
    Lice: Haematopinus suis
    Mange Mites: Sarcoptes scabiei var. suis
    Special Minor Use
    Reindeer: For the treatment and control of warbles (Oedemagena tarandi).
    American Bison: For the treatment and control of grubs (Hypoderma bovis).

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) up to a month after infection.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    To extend the persistent effect periods of Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information and to add the veal calf warning statement to the residue information section.
  • Summary
    This supplemental application extends the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days after treatment, and establishes an ADI in cattle muscle for total residues of ivermectin
  • Summary

    New claim for the treatment and control of grubs (Hypoderma bovis) in American bison.

  • Summary

    New claims for persistent control of gastrointestinal roundworms and lungworms in cattle.

  • Summary

    New tolerance for residues of ivermectin B1a in cattle liver of 100 ppb and revised safe concentration in tissues.

  • Summary
    This supplemental application is for the treatment and control of ear mites (Otodectes cynotis) in ranch-raised foxes.
  • EA 128-409
  • FONSI 128-409
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    New claim for the treatment and control of threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets via the colostrum or milk, when fed during gestation) and use of Type C medicated feed as a top dress for adult swine.

  • Summary

    To add the label claim for treatment of breeding swine.

  • Summary
    For the treatment and control of GASTROINTESTINAL ROUNDWORMS; KIDNEYWORMS; LUNGWORMS; lice and mange mites when incorporated into complete swine feeds.
  • EA 140-974
  • FONSI 140-974
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermectin Paste provides effective treatment and control of the following parasites in horses. Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S .edentatus (also tissue stages), S. equinus; Triodontophorus spp. including T. Brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidizole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyanthostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum; Small Strongyles – Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) – Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) – Parascaris equorum; Hairworms (adults) – Trichostrongylus axei; Large-mouth Stomach Worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri;
    Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
    Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This is a regulatory supplement requested by the Division of Surveillance to bring product labeling into compliance with the pioneer product. Therefore, this supplement provides for separation of small strongyle fourth-stage larvae from the small strongyle adults, which are speciated in the indication section of the product labeling. In addition, it revises the Warning statement to read “Do not use in horses intended for human consumption.”
  • Summary
    This supplement provides for the use of EQUIMAX Paste in breeding, pregnant or lactating mares without adverse effects on fertility.
  • Summary

    Indications: Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. EQUIMAX™ (ivermectin/praziquantel) Paste is indicated for the treatment and control of the following parasites:
    Tapeworms: Anoplocephala perfoliata
    Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp.
    Small Strongyles including those resistant to some benzimidazole class compounds (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.
    Pinworms (adults and fourth-stage larvae): Oxyuris equi
    Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum
    Hairworms (adults): Trichostrongylus axei
    Large-mouth Stomach Worms (adults): Habronema muscae
    Bots (oral and gastric stages): Gasterophilus spp.
    Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi
    Intestinal Threadworms (adults): Strongyloides westeri
    Summer sores caused by Habronema and Draschia spp. cutaneous third- stage larvae.
    Dermatitis caused by Neck threadworm microfilariae, Onchocerca

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Ivermectin Pour-On applied at the recommended dose level of 500mcg/kg is indicated for the effective control and treatment of these parasites: Gastrointestinal Roundworms: Ostertagia ostertagi (adults and L4) (including inhibited stage), Haemonchus placei (adults and L4), Trichostrongylus axei (adults and L4), T. colubriformis (adults and L4), Cooperia spp. adults and L4), Strongyloides papillosus (adults), Oesophagostomum radiatum (adults and L4), Trichuris spp. (adults). Lungworms: Dictyocaulus viviparus (adults and L4). Cattle Grubs: (parasitic stages): Hypoderma bovis, H. lineatum. Mites: Sarcoptes scabiei var. bovis. Lice: Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenopotes capillatus. Horn Flies: Haematobia irritants. Phoenectin™ Pour-On has been proved to effectively control infections and to protect cattle from re-infection with Ostertagia ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.

  • Summary

    For the control of the following parasites: gastrointestinal roundworms (Ostertagia ostertagi, adult and fourth stage larvae including inhibited stage; Haemonchus placei, adults and fourth stage larvae; Trichostrongylus axei, adults and fourth stage larvae; T. colubriformis, adults and fourth stage larvae; Cooperia spp., adults and fourth stage larvae; Strongyloides papillosus, adults; Oesophagostomum radiatum, adults and fourth stage larvae; O. venulosum, adults only; Trichuris spp., adults: lungworms (Dictyocaulus viviparus, adults and fourth stage larvae); cattle grubs (Hypoderma bovis, H. lineatum, parasitic stages); mites (Sarcoptes scabei var. bovis, Chorioptes bovis); lice (Linognathus vituli, Haematopinus eurysternus, Damalina bovis, Solenoptes capillatus); and horn flies (Haematobia irritans).

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for the extension of persistent activity claims against the following parasites that are no longer protected by marketing exclusivity: Oesophagostomum radiatum from 14 to 28 days after treatment, and persistent activity against Trichostrongylus axei and Cooperia punctata from 14 to 21 days after treatment.

  • Summary
    Cattle: PhoenectinTM Injection is indicated in for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice and mange mites in cattle. Swine: PhoenectinTM Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine. Special Minor Use: Reindeer: For the treatment and control of warbles (Oedemagena tarandi) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under Administration.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For the treatment and control of large strongyles (adult) (Strongylus equinus), (adult and arterial larval stages) (Strongylus vulgaris),(adult and migrating tissue stages)(Strongylus endentatus) (adult) (Triodontophorus spp.); small strongyles (adult and fourth stage larvae) (Cyathostomum spp. Cylicocyclus spp., Cylicodontophorus spp.Cylicostephanus spp.);pinworms (adult and fourth stage larvae) (Oxyuris equi); ascarids (third- and fourth-stage larvae and adults) (Parascaris equorum);hairworms (adult) (Trichostongylus axei);large mouth stomach worms (adult) (Habronemamuscae);stomach bots (oral and gastric stages) (Gastrophilus spp.); lungworms (adults and fourth stage larvae) (Dictyocaulusarnfieldi); intestinal threadworms (adults) (Strongyloides westeri); summer sores caused by Habronema and Draschia spp. cutaneous third stage larvae; and dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    ACAREXX is indicated for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older. Effectiveness against eggs and immature stages has not been proven.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the prevention of heartworm disease caused by Dirofilaria immitis. Also indicated for the treatment of flea infestation ( Ctenocephalides felis).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    The effect of the supplement is to incorporate CVM requested changes to the label’s “WARNING” and “INDICATIONS” sections and to add expired three-year exclusivity claims
  • Summary
    For the treatment and control of parasitic conditions.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Heartgard® for Cats is indicated for the prevention of feline heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis) for a month (30 days) after infection, and for the removal and control of adult and immature (L4) hookworms ( Ancylostoma tubaeforme and A. braziliense).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement expands the indications to include the treatment and control of adult hookworms ( Ancylostoma braziliense).
  • Summary
    Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel pamoate (for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum and Uncinaria stenocephala) in dogs.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For use in dogs to prevent canine heartworm disease. HEARTGARD-30 (ivermectin) eliminates the tissue stage of heartworm larvae ( Dirofilaria immitis ).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for removal of the following statement from the Precautions section of the package insert: “The effective use of this drug for the treatment and control of tapeworms has not been evaluated in dogs less than 15 pounds.”
  • Summary
    For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae ( Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms ( Toxocara canis, Toxascaris leonina), hookworms ( Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworms ( Dipylidium caninum, Taenia pisiformis).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Iverhart is indicated for the prevention of canine heartworm (Dirofilaria immitis) disease
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment and control of gastrointestinal roundworms, lungworms, lice and mange mites in cattle and swine.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Provides for reducing the predicted duration of effectiveness from "approximately 135 days" to "approximately 130 days".
  • Summary
    The Ivomec® SR Bolus is indicated for (1) the treatment of established infections and, throughout its approximately 135-day invermectin delivery period, prevents the establishment of infection by newly ingested larvae of certain nematode species, (2) treatment of established infections of certain mange mites, (3) treatment of established infections of certain sucking lice, (4) control of existing Hypoderma larvae or grubs and newly acquired larvae during the 135-day period, and (5) control of the tick Amblyomma americanum by interfering with engorgement with blood and completion of the reproductive portion of the young adult female life cycle.
  • EA 140-988
  • FONSI 140-988
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, large-mouth stomach worms, bots, lungworms, summer sores and cutaneous onchocerciasis.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Treatment and control of gastrointestinal roundworms, lungworms, and nasal bots.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

Used monthly for heartworm prevention in dogs and cats; also controls certain intestinal parasites.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Generally safe at labeled doses. Use caution in collies and herding breeds with MDR1 gene mutation at higher doses.

Side Effects

At preventive doses, side effects are rare; occasional lethargy or mild GI upset. Over-sensitivity possible in some herding breeds.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).

Dog
Digestive
Vomiting (9330) Diarrhea (4004) Vomiting (36) Vomiting (36) Vomiting (36) Vomiting (36) Vomiting (33) Vomiting (30) Diarrhea (13) Diarrhea (13) Diarrhea (13) Diarrhea (13) Diarrhea (10) Diarrhea (9)
Neurologic
Seizure NOS (14) Seizure NOS (14) Seizure NOS (14) Seizure NOS (14) Seizure NOS (13) Seizure NOS (13) Tiredness (lethargy) (12) Tiredness (lethargy) (12) Tiredness (lethargy) (12) Tiredness (lethargy) (12) Tiredness (lethargy) (10)
Effectiveness
Lack of efficacy (endoparasite) - heartworm (21609) Lack of efficacy (endoparasite) - hookworm (10346) Lack of efficacy (endoparasite) - roundworm NOS (4816) Lack of efficacy (endoparasite) - heartworm (137) Lack of efficacy (endoparasite) - heartworm (137) Lack of efficacy (endoparasite) - heartworm (137) Lack of efficacy (endoparasite) - heartworm (137) Lack of efficacy (endoparasite) - heartworm (123) Lack of efficacy (endoparasite) - heartworm (114) Lack of efficacy (endoparasite) - hookworm (104) Lack of efficacy (endoparasite) - hookworm (104) Lack of efficacy (endoparasite) - hookworm (104) Lack of efficacy (endoparasite) - hookworm (104) Lack of efficacy (endoparasite) - hookworm (97) Lack of efficacy (endoparasite) - hookworm (92) Lack of efficacy (endoparasite) - roundworm NOS (16) Lack of efficacy (endoparasite) - roundworm NOS (16) Lack of efficacy (endoparasite) - roundworm NOS (16) Lack of efficacy (endoparasite) - roundworm NOS (16) Lack of efficacy (endoparasite) - roundworm NOS (16) Lack of efficacy (endoparasite) - roundworm NOS (16) Lack of efficacy (endoparasite) - tapeworm (8)
Other
INEFFECTIVE, HEARTWORM LARVAE (7790) INEFFECTIVE, HOOKS (6884) Digestive tract disorder NOS (4992) Death (14) Death (14) Death (14) Death (14) Death (14) Death (14)
Cat
Digestive
Vomiting (66) Vomiting (14) Diarrhea (12) Loss of appetite (9)
Neurologic
Tiredness (lethargy) (16) Unsteady walking (ataxia) (16)
Other
Accidental exposure (10) Death (9)

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, ['Terrier - Yorkshire', 'Bichon Frise'], Female, 15 year, 4.536 kilogram • Drug: MSK, Unknown • Reactions: Diarrhea, Vomiting, Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055882
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Diarrhea Vomiting Vomiting
Outcomes: Recovered/Normal

Dog, Shih Tzu, Female, 13 year, 6.623 kilogram • Drug: MSK, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Erythema, Behavioral disorder (unspecified), Weight loss, Bumps on skin, Skin sore… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055886
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 6.623 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Erythema Behavioral disorder (unspecified) Weight loss Bumps on skin Skin sore Decreased appetite Cyanotic spots/blotchy skin UNPALATABLE
Outcomes: Ongoing

Dog, Retriever - Labrador, Male, 7 year, 33.112 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-055716
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 33.112 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (endoparasite) - tapeworm
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Female, 8 year, 31.751 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 30 per day • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055413
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 31.751 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 30 per day
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Ongoing

Dog, Doberman Pinscher, Male, 5 month, 21.863 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - hookworm, Lack of efficacy (protozoa) - Giardia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055419
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Month
  • Weight: 21.863 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (endoparasite) - hookworm Lack of efficacy (protozoa) - Giardia
Outcomes: Ongoing

Dog, Dog (unknown), Unknown • Drug: MSK, Unknown • Reactions: Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-055624
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Death
Outcomes: Died

Cat, Cat (unknown), Male, 7 year, 7.536 kilogram • Drug: MSK, Tablet, Oral, Dose: 68 Microgram per animal, Frequency: 1 per month • Reactions: Heavy breathing, Accidental exposure, Administration error NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-041609
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 7.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 68 Microgram per animal
  • Frequency: 1 per month
Reactions Reported:
Heavy breathing Accidental exposure Administration error NOS
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 8 week, 0.998 kilogram • Drug: MSK, Unassigned, Auricular (Otic) • Reactions: Unsteady walking (ataxia), Weakness, Tiredness (lethargy), Unresponsive to stimuli • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-012198
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Week
  • Weight: 0.998 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Unassigned
Reactions Reported:
Unsteady walking (ataxia) Weakness Tiredness (lethargy) Unresponsive to stimuli
Outcomes: Recovered/Normal

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

High doses can cause neurologic symptoms (tremors, ataxia, seizures, coma). Immediate veterinary care is necessary in case of significant overdose.

Storage & Handling

Store at controlled room temperature (20–25°C / 68–77°F); protect from light and moisture. Keep out of reach of children.

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