Meds A-Z

Gentamicin

Detailed information about Gentamicin

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 prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.

What it does:

When it's needed:

Call your vet sooner if you notice:

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Commonly reported reactions:

(2 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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Gentamicin

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

Species: Both

Manufacturer: Intervet, Inc.

Quick Facts

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

Species: Both

Manufacturer: Intervet, Inc.

Form: Injection, Liquid (Solution), Liquid (Suspension), Ointment, Ophthalmic Solution, Oral Concentrate Solution

Identifiers:

ANADA: 200023 ANADA: 200037 ANADA: 200102 ANADA: 200115 ANADA: 200137 ANADA: 200147 ANADA: 200174 ANADA: 200183 ANADA: 200185 ANADA: 200188 ANADA: 200190 ANADA: 200191 ANADA: 200229 ANADA: 200273 ANADA: 200283 ANADA: 200287 ANADA: 200388 ANADA: 200394 ANADA: 200395 ANADA: 200415

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/101862 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141177 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

High: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Source metadata:

https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source

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

Reported cases

Serious reports

Species represented

Most Reported Reactions

Cases	Species	Serious cases
2	Cat, Dog	1
1	Dog	1
1	Dog	1
1	Cat	1
1	Cat	1
1	Cat	1
1	Dog	1
1	Dog	1

Species coverage: Cat (17) Dog (15)

View detailed reaction table

Species	Seriousness	Frequency	Reports
Cat	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Cat	Serious	-	1
Cat	Non-serious	-	1
Cat	Serious	-	1
Dog	Non-serious	-	1
Cat	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Cat	Non-serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Cat	Serious	-	1
Dog	Serious	-	1
Dog	Serious	-	1
Cat	Non-serious	-	1

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2024-US-079899

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 86 • Secondary summaries: 0

Official label facts

N101862_Supp_3_28_1996(2).pdf · FOI
101-862 · EA
101-862 · FONSI
Garasol® · SPL
ucm117269.pdf · FOI
ucm117268.pdf · FOI
ucm117265.pdf · FOI
Mometamax™ Otic Suspension · SPL
FOI Summary oN 141-600 Approved April 29 2025_ef.pdf · FOI
Mometamax Single™ · SPL
ucm061600.pdf · FOI
A200147_Orig_4_10_1995.pdf · FOI
GentaPoult · SPL
Genta-Ject® · SPL
UCM287927.pdf · FOI
Easotic® · SPL
GENTORAL® · SPL
UCM433786.pdf · FOI
Gentamicin Sulfate Ophthalmic Solution · SPL
A200191_Org_3_24_1997.pdf · FOI
Gentasol · SPL
UCM396874.pdf · FOI
GentaMed™-P · SPL
ucm061343.pdf · FOI
Gentamicin Piglet Injection · SPL
A200174_Org_4_10_1997.pdf · FOI
Gentamicin Sulfate Pig Pump Oral Solution · SPL
Garacin® Pig Pump Oral Solution · SPL
Gentocin® Pink Eye Spray · SPL
Garasol® Solution · SPL
Garacin® Piglet Injection · SPL
UCM167677.pdf · FOI
GB Topical Spray · SPL
ucm061701.pdf · FOI
Vetro-Gen™ Veterinary Ophthalmic Ointment · SPL
UCM292012.pdf · FOI
GentaMed™ · SPL
A200115_Orig_7_21_1995.pdf · FOI
Gentamex™ 100 · SPL
A200185_Org_4_30_1997.pdf · FOI
GEN-GARD® · SPL
A200037_Org_2_8_1993.pdf · FOI
Legacy Sterile Solution · SPL
Gentamicin Sulfate Solution · SPL
A200137_Orig_11_13_1996.pdf · FOI
GentaMax® 100 · SPL
Garasol® Injection · SPL
Gentamicin Sulfate Inj. Sol. · SPL
A200023_Org_8_4_1995.pdf · FOI
Gentamicin Sulfate Solution 100 mg/ml · SPL
A200102_Orig_05_19_1994.pdf · FOI
Gentaglyde™ Solution · SPL
UCM061643.pdf · FOI
A200229_Orig_4_4_1998.pdf · FOI
Tri-Otic® Ointment · SPL
A200188_Org_1_29_97.pdf · FOI
Betagen™ Topical Spray · SPL
A200183_Org_7_31_1995.pdf · FOI
VET BETA-GEN® · SPL
N140896_Org_6_9_1993.pdf · FOI
Otomax® · SPL
Garacin® · SPL
Garacin® Soluble Powder · SPL
UCM504539.pdf · FOI
Mometavet® · SPL
ucm061716.pdf · FOI
ucm061715.pdf · FOI
ucm061714.pdf · FOI
GBC Ointment™ · SPL
ucm061346.pdf · FOI
Gentamicin Sulfate Solution · SPL
ucm061352.pdf · FOI
Gentamicin Sulfate Topical Spray · SPL
UCM292007.pdf · FOI
Gentamicin Topical Spray · SPL
UCM436590.pdf · FOI
Gentocin® Durafilm® · SPL
Gentocin® Ophthalmic Ointment · SPL
Gentocin® Ophthalmic Solution · SPL
Gentocin® Otic Solution · SPL
Gentocin® Solution · SPL
Gentocin® Solution · SPL
Gentocin® Topical Spray · SPL
Topagen® Ointment · SPL
ucm061711.pdf · FOI
Vetro-Max® · SPL

Secondary summaries

No source yet.

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1622 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadEA/116 · document · EA
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFonsi/118 · document · FONSI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1592/Garasol%C2%AE · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/689 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/688 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/687 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/489/Mometamax%E2%84%A2%20Otic%20Suspension · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16869 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17190/Mometamax%20Single%E2%84%A2 · document · SPL

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, 10:44 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, 11:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

Official (FDA)

Identity: Generic ingredient • FDA branded products available

Official FDA brands: Betagen™ Topical Spray Easotic® GB Topical Spray GBC Ointment™ GEN-GARD® GENTORAL® Garacin® Garacin® Pig Pump Oral Solution Garacin® Piglet Injection Garacin® Soluble Powder Garasol® Garasol® Injection Garasol® Solution GentaMax® 100 GentaMed™ GentaMed™-P GentaPoult Genta-Ject® Gentaglyde™ Solution Gentamex™ 100 Gentamicin Piglet Injection Gentamicin Sulfate Inj. Sol. Gentamicin Sulfate Ophthalmic Solution Gentamicin Sulfate Pig Pump Oral Solution Gentamicin Sulfate Solution Gentamicin Sulfate Solution 100 mg/ml Gentamicin Sulfate Topical Spray Gentamicin Topical Spray Gentasol Gentocin® Durafilm® Gentocin® Ophthalmic Ointment Gentocin® Ophthalmic Solution Gentocin® Otic Solution Gentocin® Pink Eye Spray Gentocin® Solution Gentocin® Topical Spray Legacy Sterile Solution Gentamicin Sulfate Solution Mometamax Single™ Mometamax™ Otic Suspension Mometavet® Otomax® Topagen® Ointment Tri-Otic® Ointment VET BETA-GEN® Vetro-Gen™ Veterinary Ophthalmic Ointment Vetro-Max®

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: 1 day old chicks, 1 day-old broiler chicks, 1 to 3 days old, Cat, Dog, Eggs, Horse, Neonate, Neonate or suckling, No Use Class Stated Or Implied, No use class stated or implied, Poults 1 to 3 Day Old, Weanling

Rx/OTC: OTC, RX

Form/route: Injection, Liquid (Solution), Liquid (Suspension), Ointment, Ophthalmic Solution, Oral Concentrate Solution, Otic Suspension, Soluble Powder, Solution, Spray, Suspension • Immersion, Intramuscular, Intrasynovial, Intrauterine, Ophthalmic, Oral, Otic, Subcutaneous, Topical

Applications: NADA 101-862 • NADA 141-177 • NADA 141-600 • ANADA 200-147 • NADA 141-330 • ANADA 200-190 • ANADA 200-576 • ANADA 200-191 • ANADA 200-468 • ANADA 200-394 • ANADA 200-174 • NADA 130-464 • NADA 130-952 • NADA 92523 • NADA 103-037 • ANADA 200-388 • ANADA 200-273 • ANADA 200-494 • ANADA 200-115 • ANADA 200-185 • ANADA 200-037 • ANADA 200-137 • NADA 47486 • NADA 137-310 • ANADA 200-023 • ANADA 200-102 • ANADA 200-229 • ANADA 200-188 • ANADA 200-183 • NADA 140-896 • NADA 91191 • NADA 133-836 • ANADA 200-536 • ANADA 200-287 • ANADA 200-395 • ANADA 200-415 • ANADA 200-416 • NADA 34267 • NADA 98989 • NADA 99008 • NADA 46821 • NADA 38292 • NADA 46724 • NADA 132-338 • NADA 113-231 • ANADA 200-283

Documents: 38 (FOI: 36) • SPL: 48 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 56 • Cat 8 • View

Case summaries: 10 (showing 8) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Conjunctivitis Dystocia Metritis Otitis Externa (Ear Infection) Pica Pneumonia (aspiration, bacterial, viral) Pyoderma (superficial/deep) Urinary tract infection (cystitis)

Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes

ICD10_CM: H60.90

Otitis externa, unspecified ear

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

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)

Top reaction signals

Abnormal breathing (1) Abnormal radiograph finding (1) Abnormal ultrasound finding (1) Active urine sediment (1) Azotaemia (1) Blood in vomit (1) Bloody diarrhoea (1) Congestive heart failure (1) Cough (1) Cystitis (1) Deafness (1) Decreased appetite (1) Dental calculus (1) Diarrhoea (1) Diarrhoea (1) Digestive tract hypomotility (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	Status
0061-0100-01	0061	-
0061-0134-01	0061	-
0061-0387-01	0061	-
0061-0387-02	0061	-
0061-0387-03	0061	-
0061-0387-08	0061	-
0061-0387-17	0061	-
0061-1246-01	0061	-
0061-1246-02	0061	-
0061-1246-04	0061	-
0061-1246-05	0061	-
0061-5432-01	0061	-
11695-4153-1	11695	-
11695-4153-2	11695	-
11695-7009-1	11695	-
11695-7009-2	11695	-
11695-7009-3	11695	-
13985-566-12	13985	-
13985-566-24	13985	-
13985-566-60	13985	-

Enriched Documents

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

N101862_Supp_3_28_1996(2).pdf • FOI summary • Official • Feb. 3, 2026
FDA FOI summary for application 101862
ucm117265.pdf • FOI summary • Official • Dec. 3, 2025
FDA FOI summary for application 141177
ucm117268.pdf • FOI summary • Official • Dec. 3, 2025
FDA FOI summary for application 141177
ucm117269.pdf • FOI summary • Official • Dec. 3, 2025
FDA FOI summary for application 141177
FOI Summary oN 141-600 Approved April 29 2025_ef.pdf • FOI summary • Official • June 3, 2025
FDA FOI summary for application 141600
A200147_Orig_4_10_1995.pdf • FOI summary • Official • July 3, 2024
FDA FOI summary for application 200147
ucm061600.pdf • FOI summary • Official • July 3, 2024
FDA FOI summary for application 200147
UCM287927.pdf • FOI summary • Official • May 14, 2024
FDA FOI summary for application 141330
UCM433786.pdf • FOI summary • Official • Dec. 14, 2023
FDA FOI summary for application 200576
A200191_Org_3_24_1997.pdf • FOI summary • Official • Aug. 25, 2023
FDA FOI summary for application 200191
UCM396874.pdf • FOI summary • Official • April 26, 2023
FDA FOI summary for application 200468
ucm061343.pdf • FOI summary • Official • April 26, 2023
FDA FOI summary for application 200394
A200174_Org_4_10_1997.pdf • FOI summary • Official • April 26, 2023
FDA FOI summary for application 200174
UCM167677.pdf • FOI summary • Official • Oct. 1, 2019
FDA FOI summary for application 200388
ucm061701.pdf • FOI summary • Official • Oct. 1, 2019
FDA FOI summary for application 200273
UCM292012.pdf • FOI summary • Official • Oct. 2, 2018
FDA FOI summary for application 200494
A200115_Orig_7_21_1995.pdf • FOI summary • Official • Oct. 2, 2018
FDA FOI summary for application 200115
A200185_Org_4_30_1997.pdf • FOI summary • Official • July 2, 2018
FDA FOI summary for application 200185
A200037_Org_2_8_1993.pdf • FOI summary • Official • July 2, 2018
FDA FOI summary for application 200037
A200137_Orig_11_13_1996.pdf • FOI summary • Official • June 19, 2018
FDA FOI summary for application 200137
A200023_Org_8_4_1995.pdf • FOI summary • Official • Feb. 1, 2018
FDA FOI summary for application 200023
A200102_Orig_05_19_1994.pdf • FOI summary • Official • July 19, 2017
FDA FOI summary for application 200102
A200229_Orig_4_4_1998.pdf • FOI summary • Official • July 12, 2017
FDA FOI summary for application 200229
UCM061643.pdf • FOI summary • Official • July 12, 2017
FDA FOI summary for application 200229
A200188_Org_1_29_97.pdf • FOI summary • Official • May 22, 2017
FDA FOI summary for application 200188
A200183_Org_7_31_1995.pdf • FOI summary • Official • May 22, 2017
FDA FOI summary for application 200183
N140896_Org_6_9_1993.pdf • FOI summary • Official • May 17, 2017
FDA FOI summary for application 140896
UCM504539.pdf • FOI summary • Official • Aug. 16, 2016
FDA FOI summary for application 200536
UCM292007.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200416
ucm061352.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200415
ucm061346.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200395
ucm061714.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200287
ucm061715.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200287
ucm061716.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200287
ucm061711.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200283
UCM436590.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 34267

Data Sources & Revision History

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

Official 39 Clinical 0 Manufacturer 0 Marketing 0

Current Field Facts

contraindications: If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on… (Official, 2026-02-12)
side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Vomiting, Lethargy (see also Central nervous system depr… (Official, 2026-02-12)
usage: For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (t… (Official, 2026-02-12)

Recent Revisions

side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
usage updated 2026-02-12 22:44 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
Garasol® RX Gentamicin Sulfate Liquid (Solution) • Subcutaneous Label highlights Official documents	Intervet, Inc.	NADA 101-862	Approved	Feb 3, 2026
Mometamax™ Otic Suspension RX Clotrimazole Gentamicin Sulfate Mometasone Furoate Monohydrate Liquid (Suspension) • Topical Label highlights Official documents	Intervet, Inc.	NADA 141-177	Approved	Dec 3, 2025
Mometamax Single™ RX Gentamicin Mometasone furoate posaconazole Otic Suspension • Otic Label highlights Official documents	Intervet, Inc.	NADA 141-600	Approved	Jun 3, 2025
GentaPoult Genta-Ject® RX Gentamicin Sulfate Liquid (Solution) • Subcutaneous Label highlights Official documents	Huvepharma EOOD	ANADA 200-147	Approved	Jul 3, 2024
Easotic® RX Gentamicin Sulfate Hydrocortisone aceponate Miconazole Nitrate Otic Suspension • Otic Label highlights Official documents	Virbac AH, Inc.	NADA 141-330	Approved	May 14, 2024
GENTORAL® RX Gentamicin Sulfate Oral Concentrate Solution • Oral Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-190	W	Dec 26, 2023
Gentamicin Sulfate Ophthalmic Solution RX Gentamicin Sulfate Ophthalmic Solution • Ophthalmic Label highlights Official documents	Domes Pharma S.A.	ANADA 200-576	Approved	Dec 14, 2023
Gentasol OTC Gentamicin Sulfate Liquid (Solution) • Immersion Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-191	W	Aug 25, 2023
GentaMed™-P RX Gentamicin Sulfate Injection • Subcutaneous Label highlights Official documents	Bimeda Animal Health Limited	ANADA 200-468	Approved	Apr 26, 2023
Gentamicin Piglet Injection RX Gentamicin Sulfate Liquid (Solution) • Intramuscular Label highlights Official documents	Sparhawk Laboratories, Inc.	ANADA 200-394	Approved	Apr 26, 2023
Gentamicin Sulfate Pig Pump Oral Solution RX Gentamicin Sulfate Liquid (Solution) • Oral Label highlights Official documents	Huvepharma EOOD	ANADA 200-174	Approved	Apr 26, 2023
Garacin® Pig Pump Oral Solution RX Gentamicin Sulfate Liquid (Solution) • Oral Label highlights Official documents	Intervet, Inc.	NADA 130-464	Approved	Mar 2, 2023
Gentocin® Pink Eye Spray RX Gentamicin Sulfate Spray • Ophthalmic Label highlights Official documents	Intervet, Inc.	NADA 130-952	Approved	Jan 12, 2023
Garasol® Solution RX Gentamicin Sulfate Liquid (Solution) • Immersion Label highlights Official documents	Intervet, Inc.	NADA 92523	Approved	Dec 22, 2022
Garacin® Piglet Injection RX Gentamicin Sulfate Liquid (Solution) • Intramuscular Label highlights Official documents	Intervet, Inc.	NADA 103-037	Approved	Dec 16, 2022
GB Topical Spray RX Betamethasone Valerate Gentamicin Sulfate Liquid (Solution) • Topical Label highlights Official documents	Dechra Veterinary Products LLC	ANADA 200-388	Approved	Oct 1, 2019
Vetro-Gen™ Veterinary Ophthalmic Ointment OTC Gentamicin Sulfate Ointment • Topical Label highlights Official documents	Dechra Veterinary Products LLC	ANADA 200-273	Approved	Oct 1, 2019
GentaMed™ RX Gentamicin Sulfate Soluble Powder • Oral Label highlights Official documents	Bimeda Animal Health Limited	ANADA 200-494	Approved	Oct 2, 2018
Gentamex™ 100 RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Bimeda Animal Health Limited	ANADA 200-115	Approved	Oct 2, 2018
GEN-GARD® RX Gentamicin Sulfate Soluble Powder • Oral Label highlights Official documents	Huvepharma EOOD	ANADA 200-185	Approved	Jul 2, 2018
Legacy Sterile Solution Gentamicin Sulfate Solution RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Huvepharma EOOD	ANADA 200-037	Approved	Jul 2, 2018
GentaMax® 100 RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Elanco US Inc.	ANADA 200-137	Approved	Jun 19, 2018
Garasol® Injection OTC Gentamicin Sulfate Liquid (Solution) • Subcutaneous Label highlights Official documents	Intervet, Inc.	NADA 47486	W	Mar 2, 2018
Gentamicin Sulfate Inj. Sol. RX Gentamicin Sulfate Liquid (Solution) • Intrasynovial, Intramuscular Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	NADA 137-310	Approved	Feb 1, 2018
Gentamicin Sulfate Solution 100 mg/ml RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-023	Approved	Feb 1, 2018
Gentaglyde™ Solution RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Zoetis Inc.	ANADA 200-102	Approved	Jul 19, 2017
Tri-Otic® Ointment RX Betamethasone Valerate Clotrimazole Gentamicin Sulfate Ointment • Topical Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-229	Approved	Jul 12, 2017
Betagen™ Topical Spray RX Betamethasone Valerate Gentamicin Sulfate Spray • Topical Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-188	Approved	May 22, 2017
VET BETA-GEN® RX Betamethasone Valerate Gentamicin Sulfate Liquid (Solution) • Topical Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-183	Approved	May 22, 2017
Otomax® RX Betamethasone Valerate Clotrimazole Gentamicin Sulfate Ointment • Topical Label highlights Official documents	Intervet, Inc.	NADA 140-896	Approved	May 17, 2017
Garacin® RX Gentamicin Sulfate Oral Concentrate Solution • Oral Label highlights Official documents	Intervet, Inc.	NADA 91191	Approved	Jan 3, 2017
Garacin® Soluble Powder RX Gentamicin Sulfate Soluble Powder • Oral Label highlights Official documents	Intervet, Inc.	NADA 133-836	Approved	Jan 3, 2017
Mometavet® RX Clotrimazole Gentamicin Sulfate Mometasone furoate Suspension • Otic Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-536	Approved	Aug 16, 2016
GBC Ointment™ RX Betamethasone Valerate Clotrimazole Gentamicin Sulfate Ointment • Topical Label highlights Official documents	Cronus Pharma Specialities India Private Ltd.	ANADA 200-287	Approved	Jun 1, 2016
Gentamicin Sulfate Solution RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Sparhawk Laboratories, Inc.	ANADA 200-395	Approved	Jun 1, 2016
Gentamicin Sulfate Topical Spray RX Betamethasone Valerate Gentamicin Sulfate Spray • Topical Label highlights Official documents	First Priority, Inc.	ANADA 200-415	Approved	Jun 1, 2016
Gentamicin Topical Spray RX Betamethasone Valerate Gentamicin Sulfate Spray • Topical Label highlights Official documents	Sparhawk Laboratories, Inc.	ANADA 200-416	Approved	Jun 1, 2016
Gentocin® Durafilm® RX Betamethasone Acetate Gentamicin Sulfate Solution • Ophthalmic Label highlights Official documents	Intervet, Inc.	NADA 34267	Approved	Jun 1, 2016
Gentocin® Ophthalmic Ointment OTC Gentamicin Sulfate Ointment • Ophthalmic Label highlights Official documents	Intervet, Inc.	NADA 98989	Approved	Jun 1, 2016
Gentocin® Ophthalmic Solution RX Gentamicin Sulfate Liquid (Solution) • Ophthalmic Label highlights Official documents	Intervet, Inc.	NADA 99008	Approved	Jun 1, 2016
Gentocin® Otic Solution RX Betamethasone Valerate Gentamicin Sulfate Liquid (Solution) • Topical Label highlights Official documents	Intervet, Inc.	NADA 46821	Approved	Jun 1, 2016
Gentocin® Solution RX Gentamicin Sulfate Liquid (Solution) • Subcutaneous, Intramuscular Label highlights Official documents	Intervet, Inc.	NADA 38292	Approved	Jun 1, 2016
Gentocin® Solution RX Gentamicin Sulfate Liquid (Solution) • Intrauterine Label highlights Official documents	Intervet, Inc.	NADA 46724	Approved	Jun 1, 2016
Gentocin® Topical Spray RX Betamethasone Valerate Gentamicin Sulfate Spray • Topical Label highlights Official documents	Intervet, Inc.	NADA 132-338	Approved	Jun 1, 2016
Topagen® Ointment RX Betamethasone Valerate Gentamicin Sulfate Ointment • Topical Label highlights Official documents	Intervet, Inc.	NADA 113-231	Approved	Jun 1, 2016
Vetro-Max® RX Betamethasone Valerate Clotrimazole Gentamicin Sulfate Ointment • Topical Label highlights Official documents	Fougera Pharmaceuticals, Inc.	ANADA 200-283	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: Poults 1 to 3 Day Old • 1 day-old broiler chicks

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of 50 or 100 milligrams of gentamicin.

Chickens (day-old)

Indication

For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.

Dosage

0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter. Administer aseptically injecting the diluted product subcutaneously in the neck.

Limitations

For use in day-old chickens only. Do not slaughter treated animals for food for at least 5 weeks after treatment.

Turkeys (1- to 3-day-old poults)

Indication

As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin sulfate.

Dosage

One milligram of gentamicin per poult, using a 5 milligram-per-milliliter solution. Administer subcutaneously in the neck.

Limitations

Injected poults must not be slaughtered for food for at least 9 weeks after treatment.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each gram contains 3 mg gentamicin base; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 10 mg clotrimazole, in a mineral oil-based system containing a plasticized hydrocarbon gel.

Dogs

Indication

For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas species [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

Dosage

For dogs weighing less than 30 lbs, instill 4 drops from the 7.5g, 15g, or 30g bottle into the ear canal (2 drops from the 215g bottle) or, for dogs weighing 30 lbs or more, instill 8 drops from the 7.5g, 15g or 30g bottle into the ear canal (4 drops from the 215g bottle), once daily for 7 days.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications

A 0.8 mL dose delivers 6.88 mg gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.

Dogs

Indication

For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.

Dosage

Mometamax Single™ should be administered by veterinary personnel. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Poults 1 to 3 Day Old • 1 day-old broiler chicks

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of 100 milligrams of gentamicin.

Turkeys (1 to 3 day old poults)

Indication

As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.

Dosage

One milligram of gentamicin per 0.2 milliliter dose, using the 50-100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 5 milligrams-per-milliliter.

Limitations

For 1 to 3 day old turkey poults. Administer subcutaneously in the neck. Injected poults must not be slaughtered for food for at least 9 weeks after treatment.

Chickens (day-old)

Indication

For prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.

Dosage

0.2 milligram of gentamicin per 0.2 milliliter dose, using a 50 milligram-per-milliliter solution diluted with sterile physiological saline to 1.0 milligram per milliliter.

Limitations

Do not slaughter treated animals for food for at least 5 weeks after treatment. Administer aseptically injecting the diluted product subcutaneously in the neck.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

1.11 mg/mL hydrocortisone aceponate, 17.4 mg/mL miconazole nitrate, 1.5 mg/mL gentamicin sulfate

Dogs

Indication

For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius).

Dosage

Verify that the tympanic membrane is intact. Carefully insert the canula into the affected external ear canal(s) and apply 1 mL (a single pump) once per day for 5 days. Wash hands after usage.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Weanling

Composition / specifications

Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin.

Swine (weanling)

Indication

In weanling swine for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin.

Dosage

1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligrams per pound per day.

Limitations

Federal Law restricts this drug to use by or on the order of a licensed veterinarian. For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Treatment may be repeated if dysentery recurs. Do not slaughter treated swine for food for at least 3 days following treatment.

Swine

Indication

In swine for control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.

Dosage

1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligrams per pound per day.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied

Composition / specifications

Gentamicin sulfate equivalent to 3.0 mg gentamicin per mL of solution

Label highlights

Indication

For the topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats

Dosage

Instill 1 or 2 drops into the conjunctival sac 2 to 4 times a day

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: Eggs, excluding eggs for human consumption

Composition / specifications

Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.

Turkey (eggs)

Indication

The drug is recommended as an aid in the reduction or elimination of the following microorganisms from turkey-hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, and Mycoplasma meleagris.

Dosage

The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is recommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 minutes followed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 4 hours at approximately 40 degrees F, keeping eggs submerged for 10- 15 minutes.

Limitations

For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food.

FDA page: Open in Animal Drugs @ FDA

Species: Poults 1 to 3 Day Old • 1 day old chicks

Chickens

Indication

For the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.

Dosage

0.2 milligram of gentamicin per 0.2 milliliter dose.

Limitations

Turkeys

Indication

As an aid in the prevention of early mortality of 1 to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.

Dosage

One (1) milligram of gentamicin per 0.2 milliliter dose.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: 1 to 3 days old

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of 5 milligrams of gentamicin.

Swine

Indication

In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin

Dosage

5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution.

Limitations

For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment

FDA page: Open in Animal Drugs @ FDA

Species: Neonate or suckling

Composition / specifications

Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 5 milligrams of gentamicin.

Swine (neonatal, 1 to 3 days of age)

Indication

For the control and treatment of colibacillosis in neonatal pigs 1-3 days of age, caused by strains of E. coli sensitive to gentamicin.

Dosage

Administer 1 mL of pig pump oral solution (5 mg of gentamicin) orally per pig one time.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Neonate

Composition / specifications

Each milliliter of pig pump oral solution contains gentamicin sulfate equivalent to 4.35 milligrams of gentamicin.

Swine (neonatal)

Indication

In neonatal swine 1 to 3 days of age for control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin.

Dosage

Administer 1.15 milliliters of pig pump oral solution (5 mg of gentamicin) orally per pig one time.

Limitations

For use in neonatal swine only.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied

Composition / specifications

Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.

Cattle

Indication

The drug is indicated for the treatment of pink eye in cattle (infectious bovine keratoconjunctivitis) caused by Moraxella bovis.

Dosage

One actuation of the sprayer delivers 0.7 milliliter containing 0.75 milligram gentamicin. The sprayer should be held upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pumped once. It is advisable to treat once a day for up to 3 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Eggs, excluding eggs for human consumption

Composition / specifications

Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.

Turkey (eggs)

Indication

Dosage

The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is recommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 minutes followed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 6 hours at approximately 100 °F then immediately dipping them in gentamicin solution maintained at about 40 °F, and held completely submerged for 10 to 15minutes.

Limitations

For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food.

FDA page: Open in Animal Drugs @ FDA

Species: 1 to 3 days old

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of 5 milligrams of gentamicin.

Swine

Indication

In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin.

Dosage

5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution.

Limitations

For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Amount: Each mL contains: gentamicin sulfate, USP equivalent to 0.57 mg gentamicin base and betamethasone valerate, USP equivalent to 0.284 mg betamethasone.

Dogs

Indication

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

Dosage

Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days.

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 • Cat, No Use Class Stated Or Implied

Composition / specifications

Each gram of sterile ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

Dogs

Indication

The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.

Dosage

Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication

The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.

Dosage

Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.

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: No use class stated or implied

Composition / specifications

Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 333.3 milligrams of gentamicin. 120 grams of gentamicin per 360 gram jar.

Swine (weanling)

Indication

For the control and treatment of colibacillosis in weaning swine caused by strains of Escherichia coli sensitive to gentamicin.

Dosage

25 mg gentamicin per gallon (1 level scoop/240 gallons) of drinking water, for three consecutive days to provide 0.5 mg/lb/day. (Note: the jar contains a scoop that provides approximately 18 g of product when level full.) For proportioner use, add 1 level scoop to 2 gallons stock solution and dispense at the rate of 1 oz/gal drinking water (25 mg/gal).

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Swine

Indication

For the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

Dosage

50 mg gentamicin per gallon (1 level scoop/120 gallons) for three consecutive days to ensure a gentamicin dosage of approximately 1.0 mg/lb/day. (Note: the jar contains a scoop that provides approximately 18 g of product when level full.)

For proportioner use, add 1 level scoop to 1 gallons stock solution and dispense at the rate of 1 oz/gal drinking water (50 mg/gal).

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, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication

The drug is indicated for use for control of bacterial infections of the uterus in horses (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.

Dosage

It is administered at a dosage level of 2 to 2.5 grams per day for 3 to 5 days during estrus, each dose being diluted with 200 to 500 milliliters of sterile physiological saline before aseptic infusion into the uterus.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Weanling

Composition / specifications

Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 333.3 milligrams of gentamicin.

Swine (weanling)

Indication

For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin.

Dosage

Administer gentamicin sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking water to provide 0.5 milligram per pound of body weight per day for 3 consecutive days.

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Do not slaughter treated swine for food for at least 10 days following treatment. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Swine

Indication

For control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.

Dosage

Administer gentamicin sulfate equivalent to 50 milligrams of gentamicin per gallon of drinking water to provide 1.0 milligram per pound of body weight per day for 3 consecutive days. Treatment may be repeated if dysentery recurs.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication

Dosage

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication

Dosage

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Poults 1 to 3 Day Old

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of 5 milligrams of gentamicin.

Turkeys (1- to 3-day old poults)

Indication

As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.

Dosage

One milligram of gentamicin per poult, using a 5 milligram-per-milliliter solution. Administer subcutaneously in the neck.

Limitations

For 1- to 3-day old turkey poults.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of 50 milligrams of gentamicin.

Dogs

Indication

For use in the treatment of urinary tract infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and Staphylococcus aureus.

Dosage

2 milligrams of gentamicin per pound of body weight, twice daily on the first day, then once daily. Administer intramuscularly or subcutaneously.

Limitations

If no improvement is seen after 3 days treatment should be discontinued and the diagnosis reevaluated. Treatment not to exceed 7 days. 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, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses (mares)

Indication

Dosage

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption

FDA page: Open in Animal Drugs @ FDA

Species: Horse, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses

Indication

Dosage

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, Restricted During Pregnancy

Composition / specifications

Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams gentamicin base, betamethasone valerate equivalent to 1 milligram betamethasone, and 10 milligrams clotrimazole.

Dogs

Indication

The drug is used for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis), and/or bacteria susceptible to gentamicin.

Dosage

From 7.5- or 15-g tube; 10-, 15-, or 25-g bottles install 4 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more. From 215-g bottle, instill 2 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 4 drops twice daily for dogs weighing 30 pounds or more. Therapy should continue for 7 consecutive days. The external ear should be cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc. with suitable solutions. Excessive hair should be clipped from the treatment area. If hypersensitivity occurs, treatment should be discontinued and alternate therapy instituted.

Limitations

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition, followed by dystocia, fetal death, retained placenta and metritis. 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 milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram of gentamicin base and betamethasone valerate equivalent to 0.284 milligram of betamethasone.

Dogs

Indication

The drug is used in dogs in the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

Dosage

The lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. One actuation of the sprayer delivers 0.7 milliliter of the spray. The drug should be administered with two spray actuations 2 to 4 times daily for 7 days.

Limitations

If hypersensitivity to any of the components occurs treatment should be discontinued and appropriate therapy instituted. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. 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 • Cat, No Use Class Stated Or Implied

Composition / specifications

Each cubic centimeter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone alcohol.

Dogs

Indication

For the treatment of acute and chronic canine otitis externa caused by bacteria sensitive to gentamicin

Dosage

The drug is administered by instillation of 3 to 8 drops of solution into the ear canal twice daily for 7 to 14 days. Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. The external ear and ear canal should be properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear.

Limitations

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

Dogs

Indication

For the treatment of canine superficial infected lesions caused by bacteria sensitive to gentamicin.

Dosage

The lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days.

Limitations

Cats

Indication

For the treatment of acute and chronic canine otitis externa caused by bacteria sensitive to gentamicin.

Dosage

Limitations

Cats

Indication

For the treatment of feline superficial infected lesions caused by bacteria sensitive to gentamicin.

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams gentamicin base, betamethasone valerate equivalent to 1 milligrams betamethasone, and 10 milligrams clotrimazole.

Dogs

Indication

The drug is used for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis), and/or bacteria susceptible to gentamicin.

Dosage

From 215 gram bottle, instill 2 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 4 drops twice daily for dogs weighing 30 pounds or more.

Limitations

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

The drug is used for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis), and/or bacteria susceptible to gentamicin.

Dosage

From 7.5 or 15 gram tubes, install 4 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more.

Limitations

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Weanling

Composition / specifications

Each mL contains gentamicin sulfate veterinary, equivalent to 50 mg gentamicin base.

Swine

Indication

In swine for control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.

Dosage

1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram per pound per day.

Limitations

For use in swine drinking water only. Do not store or offer medicated drinking water in rusty containers since the drug is quickly destroyed in such containers. Medicated drinking water should be prepared daily and be the sole source of drinking water for 3 consecutive days. Treatment may be repeated if dysentery recurs. Do not slaughter treated swine for food for at least 3 days following treatment.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Weanling

Composition / specifications

Each gram of gentamicin sulfate soluble powder contains gentamicin sulfate equivalent to 16.7, 66.7, or 333.3 milligrams of gentamicin.

Swine (weanling)

Indication

For control and treatment of colibacillosis caused by strains of E. coli sensitive to gentamicin.

Dosage

Gentamicin sulfate equivalent to 25 milligrams of gentamicin per gallon of drinking water for 3 consecutive days, to provide 0.5 milligram per pound of body weight per day.

Limitations

Swine

Indication

For control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.

Dosage

Gentamicin sulfate equivalent to 50 milligrams of gentamicin per gallon of drinking water for 3 consecutive days, to provide 1 milligram per pound of body weight per day.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each gram contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate anhydrous, USP equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP.

Dogs

Indication

For the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

Dosage

For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) once daily in the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily in the ear canal. Therapy should continue for 7 consecutive days.

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, Restricted During Pregnancy

Composition / specifications

Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams gentamicin base, betamethasone valerate equivalent to 1 milligrams betamethasone, and 10 milligrams clotrimazole.

Dogs

Indication

For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

Dosage

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. From 10-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more. From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.

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, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 50 or 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses

Indication

Dosage

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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 milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram of gentamicin base and betamethasone valerate equivalent to 0.284 milligram of betamethasone.

Dogs

Indication

The drug is used in dogs in the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

Dosage

Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. The drug should be administered with two spray actuations 2 to 4 times daily for 7 days.

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

Each milliliter of spray contains gentamicin sulfate, USP equivalent to 0.57 mg of gentamicin base and betamethasone valerate, USP equivalent to 0.284 mg of betamethasone.

Dogs

Indication

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

Dosage

Administer two depressions of the sprayer head 2 to 4 times daily for 7 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Label highlights

Indication

For treatment of external eye infections and inflammation in dogs.

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied

Composition / specifications

Each gram of sterile ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

Dogs

Indication

The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.

Dosage

Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication

The drug is used for topical treatment of conjunctivitis caused by susceptible bacteria.

Dosage

Apply approximately a 1/2 inch strip to the affected eye 2 to 4 times a day.

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 • Cat, No Use Class Stated Or Implied

Composition / specifications

Each mL contains gentamicm
sulfate equivalent to 3 mg gentamicin.

Cats

Indication

GENTOCIN® Ophthalmic Solution is indicated for topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats

Dosage

1 or 2 drops instilled into the conjuctival sac 2 to 4 times a day

Limitations

Dogs

Indication

GENTOCIN® Ophthalmic Solution is indicated for topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats

Dosage

1 or 2 drops instilled into the conjuctival sac 2 to 4 times a day

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied

Composition / specifications

Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base and betamethasone valerate equivalent to 1 mg betamethasone alcohol.

Dogs

Indication

For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

Dosage

Apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs.

Dosage

Instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication

For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

Dosage

Apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

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 • Cat, No Use Class Stated Or Implied

Composition / specifications

Each milliliter of sterile aqueous solution contains the equivalent of either 5 or 50 milligrams of gentamicin.

Dogs

Indication

For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis).

Dosage

Two milligrams of gentamicin per pound of body weight, twice daily on the first day, once daily thereafter, using a 50 milligram-per-milliliter solution. Administer intramuscularly or subcutaneously.

Limitations

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication

For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia.

Dosage

Two milligrams of gentamicin per pound of body weight, twice daily on the first day, once daily thereafter, using a 50 milligram-per-milliliter solution. Administer intramuscularly or subcutaneously.

Limitations

If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. 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, Mares, Not For Food

Composition / specifications

Each milliliter of the drug contains 50 or 100 milligrams of gentamicin (as the sulfate) in sterile aqueous solution.

Horses

Indication

Dosage

Limitations

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram of gentamicin base and betamethasone valerate equivalent to 0.284 milligram of betamethasone.

Dogs

Indication

The drug is used in dogs in the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

Dosage

For the treatment of infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. One actuation of the sprayer delivers 0.7 milliliter of the spray. The drug should be administered with two spray actuations 2 to 4 times daily for 7 days.

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

Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.

Dogs

Indication

The drug is used or indicated for canine infected superficial lesions caused by bacteria sensitive to gentamicin.

Dosage

For the treatment of canine infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days.

Limitations

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian.

Indication

The drug is used or indicated for use in dogs in the treatment of acute and chronic canine otitis externa.

Dosage

For the treatment of acute and chronic canine otitis externa the drug is administered by instillation of 3 to 8 drops into the ear canal twice daily for 7 days. The external ear and ear canal should properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams gentamicin base, betamethasone valerate equivalent to 1 milligrams betamethasone, and 10 milligrams clotrimazole.

Dogs

Indication

The drug is used for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis), and/or bacteria susceptible to gentamicin.

Dosage

From 215 gram bottle, instill 2 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 4 drops twice daily for dogs weighing 30 pounds or more.

Limitations

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indication

The drug is used for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis), and/or bacteria susceptible to gentamicin.

Dosage

From 7.5 or 15 gram tubes, install 4 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more.

Limitations

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

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

Documents

FOI N101862_Supp_3_28_1996(2).pdf

Summary

This supplement provides for adding the previously approved turkey claims under NADA 47-486 to the labeling of NADA 101-862. The excipients in the formulations are identical, although the quantities are slightly different.
EA 101-862
FONSI 101-862

SPL Packages

Garasol® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm117269.pdf

Summary

New package size (7.5g bottle)
FOI ucm117268.pdf

Summary

For the treament of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis) and certain bacteria ( Pseudomonas supp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci).
FOI ucm117265.pdf

Summary

Mometamax™ Otic Suspension is indicated for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.

SPL Packages

Mometamax™ Otic Suspension (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI FOI Summary oN 141-600 Approved April 29 2025_ef.pdf

Summary

For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.

SPL Packages

Mometamax Single™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061600.pdf

Summary

This supplemental application provides for the addition of a new species (turkeys).
FOI A200147_Orig_4_10_1995.pdf

Summary

For use in the prevention of early mortality in day-old chickens caused by Escherichia coli, Salmonella typhimurium,Â and Pseudomonas aeruginosa susceptible to gentamicin sulfate.

SPL Packages

GentaPoult (ZIP)
Genta-Ject® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM287927.pdf

Summary

Easotic® suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius).

SPL Packages

Easotic® (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

GENTORAL® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM433786.pdf

Summary

For the topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.

SPL Packages

Gentamicin Sulfate Ophthalmic Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200191_Org_3_24_1997.pdf

Summary

For the reduction or elimination of the following organisms from turkey hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, Mycoplasma meleagridis.

SPL Packages

Gentasol (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM396874.pdf

Summary

Chickens: Gentamed™-P for Poultry Injection is recommended for the prevention of early mortality in day-old chickens associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.
Turkeys: As an aid in the prevention of early mortality of 1 to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.

SPL Packages

GentaMed™-P (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061343.pdf

Summary

For the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin

SPL Packages

Gentamicin Piglet Injection (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200174_Org_4_10_1997.pdf

Summary

For treatment of colibacillosis in neonatal pigs 1-3 days of age.

SPL Packages

Gentamicin Sulfate Pig Pump Oral Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Garacin® Pig Pump Oral Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Pink Eye Spray (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Garasol® Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Garacin® Piglet Injection (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM167677.pdf

Summary

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

SPL Packages

GB Topical Spray (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061701.pdf

Summary

For treatment of conjunctivitis caused by susceptible bacteria.

SPL Packages

Vetro-Gen™ Veterinary Ophthalmic Ointment (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM292012.pdf

Summary

For the control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

SPL Packages

GentaMed™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200115_Orig_7_21_1995.pdf

Summary

For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.

SPL Packages

Gentamex™ 100 (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200185_Org_4_30_1997.pdf

Summary

For the control and treatment of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin, and the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

SPL Packages

GEN-GARD® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200037_Org_2_8_1993.pdf

Summary

For the control of bacterial infections of the uterus (metritis) in horses as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.

SPL Packages

Legacy Sterile Solution (ZIP)
Gentamicin Sulfate Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200137_Orig_11_13_1996.pdf

Summary

Original Approval of NADA 200-137.

SPL Packages

GentaMax® 100 (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Garasol® Injection (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentamicin Sulfate Inj. Sol. (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200023_Org_8_4_1995.pdf

Summary

For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.

SPL Packages

Gentamicin Sulfate Solution 100 mg/ml (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200102_Orig_05_19_1994.pdf

Summary

For the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.

SPL Packages

Gentaglyde™ Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM061643.pdf

Summary

The addition of a 15 gram bottle package size made from a new material MDPE, instead of the existing LDPE or HDPE used in other sizes.
FOI A200229_Orig_4_4_1998.pdf

Summary

Tri-Otic Ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

SPL Packages

Tri-Otic® Ointment (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200188_Org_1_29_97.pdf

Summary

For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin.

SPL Packages

Betagen™ Topical Spray (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI A200183_Org_7_31_1995.pdf

Summary

For the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.

SPL Packages

VET BETA-GEN® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI N140896_Org_6_9_1993.pdf

Summary

OTOMAX is indicated for treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

SPL Packages

Otomax® (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Garacin® (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Garacin® Soluble Powder (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM504539.pdf

Summary

For the treatment of otitis externa in dogs caused by susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

SPL Packages

Mometavet® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061716.pdf

Summary

This application provides for a new container size (40 gram dropper bottle).
FOI ucm061715.pdf

Summary

This supplement provides for an additional package size, 20-gram fill in a 30 mL bottle. The bottle will be the same LDPE as the approved 15 mL bottle, and the plug, dropper and cap will be the exact same closure as the approved package.
FOI ucm061714.pdf

Summary

Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin

SPL Packages

GBC Ointment™ (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061346.pdf

Summary

Recommended for the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conceptions in mares with uterine infections caused by bacteria sensitive to gentamicin.

SPL Packages

Gentamicin Sulfate Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061352.pdf

Summary

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

SPL Packages

Gentamicin Sulfate Topical Spray (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM292007.pdf

Summary

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

SPL Packages

Gentamicin Topical Spray (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM436590.pdf

Summary

This supplement provides for a new product formulation..

SPL Packages

Gentocin® Durafilm® (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Ophthalmic Ointment (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Ophthalmic Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Otic Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Solution (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Gentocin® Topical Spray (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Topagen® Ointment (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm061711.pdf

Summary

For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

SPL Packages

Vetro-Max® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Usage

For treatment of external eye infections and inflammation in dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis). For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 56 and Cat 8 (view top reported reactions).

Top Reported Reactions (openFDA)

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

Dog

Digestive

Vomiting (12) Diarrhea (9) Blood in vomit (1) Blood in vomit (1) Blood in vomit (1) Blood in vomit (1) Blood in vomit (1) Blood in vomit (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Bloody diarrhoea (1) Diarrhea (1) Diarrhea (1) Diarrhea (1) Diarrhea (1) Diarrhea (1) Diarrhea (1)

Skin & allergy

Hives (2) Hives (2)

Neurologic

Tiredness (lethargy) (10)

Other

Temporary deafness (460) PR-EAR(S), LESION (275) Loss of hearing (232) Deafness (83) Partial deafness (8) Not eating (2) Not eating (2) Deafness (1) Deafness (1) Deafness (1) Deafness (1) Dental calculus (1) Dental calculus (1) Dental calculus (1) Dental calculus (1) Dental calculus (1) Dental calculus (1) Digestive tract hypomotility (1) Digestive tract hypomotility (1) Digestive tract hypomotility (1) Digestive tract hypomotility (1) Digestive tract hypomotility (1) Digestive tract hypomotility (1) Gastritis (1) Gastritis (1) Gastritis (1) Gastritis (1) Gastroenteritis (1) Gastroenteritis (1) Gastroenteritis (1) Gastroenteritis (1) Gut sounds increased (1) Gut sounds increased (1)

Cat

Other

Active urine sediment (3) Cough (3) Cystitis (3) Haematuria (3) Increased lung sounds (3) Increased urine concentration (3) Other abnormal test result NOS (3) Weight gain (3)

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, Retriever - Labrador, Female, 8 year, 28.12 kilogram • Drug: MSK, Unknown • Reactions: Vomiting, Not eating, Tiredness (lethargy), Pancreatitis NOS, Lack of efficacy (endoparasite) - roundworm NOS… • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-055168
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 8.00 Year
Weight: 28.120 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown

Reactions Reported:

Vomiting Not eating Tiredness (lethargy) Pancreatitis NOS Lack of efficacy (endoparasite) - roundworm NOS Other abnormal test result NOS Shaking Diarrhea Hypoalbuminaemia Hives Skin scab Gastroenteritis Non-regenerative anaemia Digestive tract hypomotility Dental calculus Bloody diarrhoea Blood in vomit Tense abdomen Gastritis Mucous stool Pale mucous membrane Gut sounds increased Lack of efficacy (ectoparasite) - flea Trembling

Outcomes: Outcome Unknown

Dog, Terrier - Australian, Female, 6 year, 8.573 kilogram • Drug: MSK, Suspension, Auricular (Otic) • Reactions: Deafness • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-054561
Serious AE: No
Treated For AE: Yes
Sex: Female
Age: 6.00 Year
Weight: 8.573 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension

Reactions Reported:

Deafness

Outcomes: Outcome Unknown

Dog, Bulldog - English, Female, 1 year, 23.405 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Not eating, Facial swelling (possible allergy), Hives, Swollen muzzle, Hypersensitivity reaction • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-048776
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 1.00 Year
Weight: 23.405 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown
Form: Unassigned

Reactions Reported:

Not eating Facial swelling (possible allergy) Hives Swollen muzzle Hypersensitivity reaction

Outcomes: Recovered/Normal

Dog, Unknown • Drug: MSK, Suspension • Reactions: Twitching, Neurological signs NOS • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-046411
Serious AE: Yes
Treated For AE: No
Sex: Unknown

Case-reported brand: MSK
Case-reported manufacturer: MSK
Form: Suspension

Reactions Reported:

Twitching Neurological signs NOS

Outcomes: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-045276
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 8.00 Year
Weight: 28.120 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Unknown

Reactions Reported:

Vomiting Not eating Tiredness (lethargy) Pancreatitis NOS Lack of efficacy (endoparasite) - roundworm NOS Other abnormal test result NOS Shaking Non-regenerative anaemia Pale mucous membrane Diarrhea Gastroenteritis Bloody diarrhoea Gastritis Blood in vomit Trembling Mucous stool Hives Hypoalbuminaemia Gut sounds increased Tense abdomen Digestive tract hypomotility Skin scab Dental calculus Lack of efficacy (ectoparasite) - flea

Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 1 year, 3.55 kilogram • Drug: MSK, Unassigned, Other • Reactions: Other abnormal test result NOS, Cystitis, Haematuria, Weight gain, Increased lung sounds… • Outcome: Ongoing

Report ID: USA-USFDACVM-2024-US-076347
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 1.00 Year
Weight: 3.550 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Other
Form: Unassigned

Reactions Reported:

Other abnormal test result NOS Cystitis Haematuria Weight gain Increased lung sounds Increased urine concentration Active urine sediment

Outcomes: Ongoing

Cat, British cat, Female, 3 month, 1.5 kilogram • Drug: MSK, Suspension • Reactions: Cough, Nasal discharge, Upper respiratory sounds • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2024-US-077320
Serious AE: No
Treated For AE: No
Sex: Female
Age: 3.00 Month
Weight: 1.500 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Form: Suspension

Reactions Reported:

Cough Nasal discharge Upper respiratory sounds

Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 1 year, 3.55 kilogram • Drug: MSK, Other • Reactions: Decreased appetite, Increased respiratory rate, Tachypnoea, Wheezing, Cough… • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2024-US-079899
Serious AE: Yes
Treated For AE: Yes
Sex: Female
Age: 1.00 Year
Weight: 3.550 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Other

Reactions Reported:

Decreased appetite Increased respiratory rate Tachypnoea Wheezing Cough Abnormal radiograph finding Abnormal breathing Abnormal ultrasound finding Congestive heart failure Heart insufficiency Haemoconcentration Azotaemia Other abnormal test result NOS Cystitis Haematuria Weight gain Increased lung sounds Increased urine concentration Active urine sediment

Outcomes: Outcome Unknown

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

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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Gentamicin

Pet Owner Quick Guide

Gentamicin

Quick Facts

Warnings / Contraindications

Adverse Reactions

Most Reported Reactions

Storage & Handling

Documents

Promotional Materials (Marketing)

At a Glance

Counseling and Monitoring Highlights

Identifiers & Packages

Enriched Documents

Data Sources & Revision History

FDA Products & Applications (Animal Drugs @ FDA)

What It's For (FDA Label Highlights)

Garasol® • Liquid (Solution) • Subcutaneous

Mometamax™ Otic Suspension • Liquid (Suspension) • Topical

Mometamax Single™ • Otic Suspension • Otic

GentaPoult Genta-Ject® • Liquid (Solution) • Subcutaneous

Easotic® • Otic Suspension • Otic

GENTORAL® • Oral Concentrate Solution • Oral

Gentamicin Sulfate Ophthalmic Solution • Ophthalmic Solution • Ophthalmic

Gentasol • Liquid (Solution) • Immersion

GentaMed™-P • Injection • Subcutaneous

Gentamicin Piglet Injection • Liquid (Solution) • Intramuscular

Gentamicin Sulfate Pig Pump Oral Solution • Liquid (Solution) • Oral

Garacin® Pig Pump Oral Solution • Liquid (Solution) • Oral

Gentocin® Pink Eye Spray • Spray • Ophthalmic

Garasol® Solution • Liquid (Solution) • Immersion

Garacin® Piglet Injection • Liquid (Solution) • Intramuscular

GB Topical Spray • Liquid (Solution) • Topical

Vetro-Gen™ Veterinary Ophthalmic Ointment • Ointment • Topical

GentaMed™ • Soluble Powder • Oral

Gentamex™ 100 • Liquid (Solution) • Intrauterine

GEN-GARD® • Soluble Powder • Oral

Legacy Sterile Solution Gentamicin Sulfate Solution • Liquid (Solution) • Intrauterine

GentaMax® 100 • Liquid (Solution) • Intrauterine

Garasol® Injection • Liquid (Solution) • Subcutaneous

Gentamicin Sulfate Inj. Sol. • Liquid (Solution) • Intrasynovial, Intramuscular

Gentamicin Sulfate Solution 100 mg/ml • Liquid (Solution) • Intrauterine

Gentaglyde™ Solution • Liquid (Solution) • Intrauterine

Tri-Otic® Ointment • Ointment • Topical

Betagen™ Topical Spray • Spray • Topical

VET BETA-GEN® • Liquid (Solution) • Topical

Otomax® • Ointment • Topical

Garacin® • Oral Concentrate Solution • Oral

Garacin® Soluble Powder • Soluble Powder • Oral

Mometavet® • Suspension • Otic

GBC Ointment™ • Ointment • Topical

Gentamicin Sulfate Solution • Liquid (Solution) • Intrauterine

Gentamicin Sulfate Topical Spray • Spray • Topical

Gentamicin Topical Spray • Spray • Topical

Gentocin® Durafilm® • Solution • Ophthalmic

Gentocin® Ophthalmic Ointment • Ointment • Ophthalmic

Gentocin® Ophthalmic Solution • Liquid (Solution) • Ophthalmic

Gentocin® Otic Solution • Liquid (Solution) • Topical

Gentocin® Solution • Liquid (Solution) • Subcutaneous, Intramuscular

Gentocin® Solution • Liquid (Solution) • Intrauterine

Gentocin® Topical Spray • Spray • Topical

Topagen® Ointment • Ointment • Topical

Vetro-Max® • Ointment • Topical

Official Documents (FDA)

Garasol® • 101862

Mometamax™ Otic Suspension • 141177

Mometamax Single™ • 141600

GentaPoult Genta-Ject® • 200147

Easotic® • 141330

GENTORAL® • 200190

Gentamicin Sulfate Ophthalmic Solution • 200576

Gentasol • 200191

GentaMed™-P • 200468

Gentamicin Piglet Injection • 200394

Gentamicin Sulfate Pig Pump Oral Solution • 200174

Garacin® Pig Pump Oral Solution • 130464

Gentocin® Pink Eye Spray • 130952

Garasol® Solution • 92523

Garacin® Piglet Injection • 103037

GB Topical Spray • 200388