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Clotrimazole

Detailed information about Clotrimazole

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 treatment of otitis externa caused by susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Pseudomonas species [including P. aeruginosa ], coagulase-positive staphylococci, Enterococcus faecal...

What it does:

For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes. The drug is used...

When it's needed:

Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install ointment twice daily into the ear canal. Therapy should continue...

Call your vet sooner if you notice:

  • Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. 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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Clotrimazole

Clotrimazole

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

Species: Both

Manufacturer: MSK

Quick Facts

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

Species: Both
Manufacturer: MSK
Form: Cream, Liquid (Suspension), Ointment, Suspension
Identifiers:
ANADA: 200229 ANADA: 200283 ANADA: 200287 ANADA: 200536 NADA: 116089 NADA: 140896 NADA: 141177 NDC Package: 0061-0387-01 NDC Package: 0061-0387-02 NDC Package: 0061-0387-03 NDC Package: 0061-0387-08 NDC Package: 0061-0387-17 NDC Package: 0061-1246-01 NDC Package: 0061-1246-02 NDC Package: 0061-1246-04 NDC Package: 0061-1246-05 NDC Package: 13985-701-07 NDC Package: 13985-701-15 NDC Package: 13985-701-21 NDC Package: 13985-701-30
Source metadata:

Warnings / Contraindications

Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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
29
Serious reports
10
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1

Species coverage: Cat (18) Dog (14)

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

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: 18 • 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, 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: GBC Ointment™ Mometamax™ Otic Suspension Mometavet® Otomax® Tri-Otic® Ointment Veltrim 1% Dermatologic Cream Vetro-Max®
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Cream, Liquid (Suspension), Ointment, Suspension • Otic, Topical
Applications: NADA 141-177 • ANADA 200-229 • NADA 140-896 • ANADA 200-536 • ANADA 200-287 • NADA 116-089 • ANADA 200-283
Documents: 11 (FOI: 11) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 48 • Cat 8 • View
Case summaries: 10 (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: 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
  • Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Abnormal menace reflex test (1) Abscess NOS (1) Balance impaired (1) Cough (1) Deafness (1) Diarrhoea (1) Drug administration duration too long (1) Elevated alanine aminotransferase (ALT) (1) Elevated blood urea nitrogen (BUN) (1) Elevated globulins (1) Glucosuria (1) Hyperglycaemia (1) Hyperproteinaemia (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Loss of hearing (1)

Identifiers & Packages

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

Identifiers
ANADA: 200229 ANADA: 200283 ANADA: 200287 ANADA: 200536 NADA: 116089 NADA: 140896 NADA: 141177 NDC Package: 0061-0387-01 NDC Package: 0061-0387-02 NDC Package: 0061-0387-03 NDC Package: 0061-0387-08 NDC Package: 0061-0387-17 NDC Package: 0061-1246-01 NDC Package: 0061-1246-02 NDC Package: 0061-1246-04 NDC Package: 0061-1246-05 NDC Package: 13985-701-07 NDC Package: 13985-701-15 NDC Package: 13985-701-21 NDC Package: 13985-701-30 NDC Package: 17030-002-01 NDC Package: 17033-273-15 NDC Package: 17033-273-21 NDC Package: 17033-273-30
Package NDC Product NDC Form / Route Status
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 -
13985-701-07 13985 -
13985-701-15 13985 -
13985-701-21 13985 -
13985-701-30 13985 -
17030-002-01 17030 -
17033-273-15 17033 -
17033-273-21 17033 -
17033-273-30 17033 -
17033-273-75 17033 -
24909-806-10 24909 -

Enriched Documents

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

  • 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
  • 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
  • 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
  • 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

Data Sources & Revision History

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

Official 14 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install oin… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Partial deafness, Drug administration duration too long. (Official, 2026-02-12)
  • usage: For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsp… (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
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
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
Otomax®
RX
Betamethasone Valerate Clotrimazole Gentamicin Sulfate
Ointment • Topical
Label highlights
Official documents
Intervet, Inc. NADA 140-896 Approved May 17, 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
Veltrim 1% Dermatologic Cream
RX
Clotrimazole
Cream • Topical
Label highlights
Official documents
Elanco US Inc. NADA 116-089 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: 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

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 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: 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: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each gram of cream contains 10 milligrams of clotrimazole.
Dogs
Indication
For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes.
Dosage
Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.
Limitations
Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats
Indication
For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes.
Dosage
Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.
Limitations
Wash hands thoroughly after use to avoid spread of infection. 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 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
  • Summary
    New package size (7.5g bottle)
  • 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).
  • 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

FDA page: Open in Animal Drugs @ FDA

Documents
  • 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.
  • 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

FDA page: Open in Animal Drugs @ FDA

Documents
  • 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

FDA page: Open in Animal Drugs @ FDA

Documents
  • 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

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This application provides for a new container size (40 gram dropper bottle).
  • 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.
  • 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

FDA page: Open in Animal Drugs @ FDA

Documents
  • 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

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes. 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.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 48 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
Effectiveness
Lack of efficacy - NOS (5) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1) Lack of efficacy - NOS (1)
Other
Temporary deafness (461) PR-EAR(S), LESION (275) Loss of hearing (233) Deafness (81) Partial deafness (8) Drug administration duration too long (6) Underdose (6) Abnormal menace reflex test (1) Abnormal menace reflex test (1) Abnormal menace reflex test (1) Abnormal menace reflex test (1) Abnormal menace reflex test (1) Abnormal menace reflex test (1) Balance impaired (1) Balance impaired (1) Balance impaired (1) Balance impaired (1) Balance impaired (1) Balance impaired (1) Deafness (1) Deafness (1) Deafness (1) Deafness (1) Loss of hearing (1) Loss of hearing (1) Loss of hearing (1) Loss of hearing (1) Loss of hearing (1) Loss of hearing (1) Loss of vision (1) Loss of vision (1) Loss of vision (1) Loss of vision (1) Loss of vision (1) Loss of vision (1) Stumbling gait (1) Stumbling gait (1) Stumbling gait (1) Stumbling gait (1) Stumbling gait (1) Stumbling gait (1)
Cat
Digestive
Diarrhea (2) Vomiting (2)
Neurologic
Tiredness (lethargy) (2)
Effectiveness
Lack of efficacy - NOS (2)
Other
Elevated alanine aminotransferase (2) Nasal discharge (2) Unclassifiable adverse event (2) Abnormal breathing (1)

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, Crossbred Canine/dog, Female, 7 year, 12.4 kilogram • Drug: MSK, Auricular (Otic) • Reactions: Loss of vision, Balance impaired, Loss of hearing, Stumbling gait, Lack of efficacy - NOS… • Outcome: Recovered with Sequela

  • Report ID: USA-USFDACVM-2025-US-054492
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.00 Year
  • Weight: 12.400 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
Reactions Reported:
Loss of vision Balance impaired Loss of hearing Stumbling gait Lack of efficacy - NOS Abnormal menace reflex test
Outcomes: Recovered with Sequela

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, 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

Dog, Retriever - Labrador, Male, 14 year, 27.669 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 8 drops per animal, Frequency: 1 per day • Reactions: Loss of hearing, Drug administration duration too long • Outcome: Recovered with Sequela

  • Report ID: USA-USFDACVM-2025-US-046917
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 27.669 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 8 drops per animal
  • Frequency: 1 per day
Reactions Reported:
Loss of hearing Drug administration duration too long
Outcomes: Recovered with Sequela

Dog, Terrier - Yorkshire, Female, 14 year • Drug: MSK, Suspension • Reactions: Loss of hearing, Medication error NOS, Tympanic rupture • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-017514
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 14.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Form: Suspension
Reactions Reported:
Loss of hearing Medication error NOS Tympanic rupture
Outcomes: Outcome Unknown

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, Female, 7 month, 2.84 kilogram • Drug: MSK, Suspension • Reactions: Lack of efficacy - NOS, Diarrhea • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-069150
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 7.00 Month
  • Weight: 2.840 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Form: Suspension
Reactions Reported:
Lack of efficacy - NOS Diarrhea
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 5 year, 8.074 kilogram • Drug: MSK, Unknown • Reactions: Vomiting, Abscess NOS, Polyuria, Polydipsia, Neutrophilia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2024-US-026147
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 8.074 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
Reactions Reported:
Vomiting Abscess NOS Polyuria Polydipsia Neutrophilia Glucosuria Hyperglycaemia Elevated alanine aminotransferase Hyperproteinaemia Elevated globulins Elevated blood urea nitrogen
Outcomes: Ongoing

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

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