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Meds A-Z

Betamethasone

Detailed information about Betamethasone

Official label facts Owner quick guide first Marketing clearly labeled
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Reviewed / Updated / Sources

Reviewed: Not available

Updated: February 12, 2026, 10:44 PM UTC

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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

What to watch for:

  • Not for use in horses intended or food
  • For use only by or on the order of a licensed veterinarian
  • It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis
  • wobbly/unsteady walking (1 reports)
  • Head shake - ear disorder (1 reports)
  • Falling (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

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?
Safety & side effects

What to watch:

  • Not for use in horses intended or food
  • For use only by or on the order of a licensed veterinarian
  • It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis
  • wobbly/unsteady walking
  • Head shake - ear disorder

Most reported reactions:

  • Unsteady walking (ataxia) (1 reports)
  • Head shake - ear disorder (1 reports)
  • Falling (1 reports)

When to call your vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Data freshness: source data appears current.

Latest refresh: Mar 21, 2026, 10:01 a.m.

Data freshness
  • Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:13 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Image coming soon
Betamethasone

Betamethasone

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: Gel, Injectable Suspension, Liquid (Solution), Liquid (Suspension), Ointment, Solution
Identifiers:
ANADA: 200183 ANADA: 200188 ANADA: 200229 ANADA: 200283 ANADA: 200287 ANADA: 200388 ANADA: 200415 ANADA: 200416 NADA: 113231 NADA: 132338 NADA: 140896 NADA: 141418 NADA: 141437 NADA: 34010 NADA: 34267 NADA: 46821 NADA: 49185 NDC Package: 0061-0100-01 NDC Package: 0061-0387-01 NDC Package: 0061-0387-02
Source metadata:

Warnings / Contraindications

Not for use in horses intended or food. For use only 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. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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.

  • High: Not for use in horses intended or food. For use only 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. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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.
Source metadata:

Adverse Reactions

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

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

Tracked signals
32
Reported cases
32
Serious reports
13
Species represented
2
Grouped by Body System
Skin & allergy (2) · Hair loss at application site, Application site pruritus Neurologic (1) · Unsteady walking (ataxia) Behavior (1) · Behavioral disorder (unspecified) Other (28) · Head shake - ear disorder, Glucosuria, Falling
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Cat (19) Dog (13)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Serious - 1
Other Dog Serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Behavior Cat Serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Other Cat Non-serious - 1
Source metadata:

Documents

Owner handouts and official technical documents are grouped for faster access.

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (1)
SPL (17)
  • Betagen™ Topical Spray · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/298/Betagen%E2%84%A2%20Topical%20Spray
  • Tri-Otic® Ointment · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1324/Tri-Otic%C2%AE%20Ointment
  • VET BETA-GEN® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/82/VET%20BETA-GEN%C2%AE
  • BetaVet® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2333/BetaVet%C2%AE
  • Osurnia™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2330/Osurnia%E2%84%A2
  • GB Topical Spray · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2018/GB%20Topical%20Spray
  • Otomax® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1200/Otomax%C2%AE
  • Betasone Aqueous Suspension · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/943/Betasone%20Aqueous%20Suspension
  • Betavet Soluspan Suspension · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/370/Betavet%20Soluspan%20Suspension
  • GBC Ointment™ · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/138/GBC%20Ointment%E2%84%A2
  • Gentamicin Sulfate Topical Spray · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/180/Gentamicin%20Sulfate%20Topical%20Spray
  • Gentamicin Topical Spray · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2242/Gentamicin%20Topical%20Spray
  • Gentocin® Durafilm® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/381/Gentocin%C2%AE%20Durafilm%C2%AE
  • Gentocin® Otic Solution · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/823/Gentocin%C2%AE%20Otic%20Solution
  • Gentocin® Topical Spray · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2127/Gentocin%C2%AE%20Topical%20Spray
  • Topagen® Ointment · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2397/Topagen%C2%AE%20Ointment
  • Vetro-Max® · SPL
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/197/Vetro-Max%C2%AE
FOI (15)
  • A200188_Org_1_29_97.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1424
  • UCM061643.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1006
  • A200229_Orig_4_4_1998.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1772
  • A200183_Org_7_31_1995.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1441
  • UCM433794.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/916
  • UCM436650.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/928
  • UCM167677.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1137
  • N140896_Org_6_9_1993.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1368
  • ucm061716.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1041
  • ucm061715.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1040
  • ucm061714.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1039
  • ucm061352.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1147
  • UCM292007.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1148
  • UCM436590.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/299
  • ucm061711.pdf · FOI
    https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1037
Source metadata:
Veterinary reference (advanced)

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 Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Mar 21, 2026, 10:01 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 Mar 21, 2026, 10:01 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:13 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:21 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: BetaVet® Betagen™ Topical Spray Betasone Aqueous Suspension Betavet Soluspan Suspension GB Topical Spray GBC Ointment™ Gentamicin Sulfate Topical Spray Gentamicin Topical Spray Gentocin® Durafilm® Gentocin® Otic Solution Gentocin® Topical Spray Osurnia™ Otomax® Topagen® Ointment Tri-Otic® Ointment VET BETA-GEN® Vetro-Max®
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Cat, Dog, Horse, No Use Class Stated Or Implied
Rx/OTC: RX
Form/route: Gel, Injectable Suspension, Liquid (Solution), Liquid (Suspension), Ointment, Solution, Spray • Intra-Articular, Intramuscular, Ophthalmic, Otic, Topical
Applications: ANADA 200-188 • ANADA 200-229 • ANADA 200-183 • NADA 141-418 • NADA 141-437 • ANADA 200-388 • NADA 140-896 • NADA 49185 • NADA 34010 • ANADA 200-287 • ANADA 200-415 • ANADA 200-416 • NADA 34267 • NADA 46821 • NADA 132-338 • NADA 113-231 • ANADA 200-283
Documents: 16 (FOI: 15) • SPL: 17 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 8 • 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 ICD10_CM: M19.90
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
  • Not for use in horses intended or food. For use only 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. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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. (Contraindication, High)
Top reaction signals
Unsteady walking (ataxia) (1) Head shake - ear disorder (1) Falling (1) Facial paralysis (1) Eye redness (1) Eye irritation (1) Excessive ear wax (1) Ear infection NOS (1)

Identifiers & Packages

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

Identifiers
ANADA: 200183 ANADA: 200188 ANADA: 200229 ANADA: 200283 ANADA: 200287 ANADA: 200388 ANADA: 200415 ANADA: 200416 NADA: 113231 NADA: 132338 NADA: 140896 NADA: 141418 NADA: 141437 NADA: 34010 NADA: 34267 NADA: 46821 NADA: 49185 NDC Package: 0061-0100-01 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: 10797-720-01
Package NDC Product NDC Form / Route Status
0061-0100-01 0061 -
0061-0387-01 0061 -
0061-0387-02 0061 -
0061-0387-03 0061 -
0061-0387-08 0061 -
0061-0387-17 0061 -
10797-720-01 10797 -
17033-277-02 17033 -
17033-277-20 17033 -
17033-283-02 17033 -
17033-283-20 17033 -

Enriched Documents

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

  • A200229_Orig_4_4_1998.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200229
  • UCM061643.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200229
  • A200188_Org_1_29_97.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200188
  • A200183_Org_7_31_1995.pdf • FOI summary • Official • Feb. 27, 2026
    FDA FOI summary for application 200183
  • N-141418-C-0022-NF-AA_PI.pdf • Official label • Official • Oct. 25, 2021
    FDA official labeling for application 141418
  • UCM433794.pdf • FOI summary • Official • Oct. 25, 2021
    FDA FOI summary for application 141418
  • UCM436650.pdf • FOI summary • Official • Aug. 11, 2020
    FDA FOI summary for application 141437
  • UCM167677.pdf • FOI summary • Official • Oct. 1, 2019
    FDA FOI summary for application 200388
  • N140896_Org_6_9_1993.pdf • FOI summary • Official • May 17, 2017
    FDA FOI summary for application 140896
  • 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
  • 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 & Change Log

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

Official 19 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Not for use in horses intended or food. For use only by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order o… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy - NOS, Loss of hearing, Ear discharge, Vomiting, Deafness, Hearing decreased. (Official, 2026-02-12)
  • usage: It is used or intended for use for the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and f… (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
Betagen™ Topical Spray
RX
Betamethasone Valerate Gentamicin Sulfate
Spray • Topical
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-188 W Feb 27, 2026
Tri-Otic® Ointment
RX
Betamethasone Valerate Clotrimazole Gentamicin Sulfate
Ointment • Topical
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-229 W Feb 27, 2026
VET BETA-GEN®
RX
Betamethasone Valerate Gentamicin Sulfate
Liquid (Solution) • Topical
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-183 W Feb 27, 2026
BetaVet®
RX
Betamethasone Acetate Betamethasone Sodium Phosphate
Injectable Suspension • Intra-Articular
Label highlights
Official documents
American Regent, Inc. NADA 141-418 Approved Oct 25, 2021
Osurnia™
RX
Betamethasone Acetate Florfenicol Terbinafine
Gel • Otic
Label highlights
Official documents
Dechra, Ltd. NADA 141-437 Approved Aug 11, 2020
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
Otomax®
RX
Betamethasone Valerate Clotrimazole Gentamicin Sulfate
Ointment • Topical
Label highlights
Official documents
Intervet, Inc. NADA 140-896 Approved May 17, 2017
Betasone Aqueous Suspension
RX
Betamethasone Dipropionate Betamethasone Sodium Phosphate
Liquid (Suspension) • Intra-Articular, Intramuscular
Label highlights
Official documents
Intervet, Inc. NADA 49185 Approved Jun 1, 2016
Betavet Soluspan Suspension
RX
Betamethasone Acetate Betamethasone Sodium Phosphate
Liquid (Suspension) • Intra-Articular
Label highlights
Official documents
Intervet, Inc. NADA 34010 Approved Jun 1, 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 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® Otic Solution
RX
Betamethasone Valerate Gentamicin Sulfate
Liquid (Solution) • Topical
Label highlights
Official documents
Intervet, Inc. NADA 46821 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: 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, 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 • 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
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.
Cats
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.
Cats
Indication
For the treatment of feline 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
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.

FDA page: Open in Animal Drugs @ FDA

Species: No Use Class Stated Or Implied
Composition / specifications
6 mg/mL as 3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate
Horses
Indication

For the control of pain and inflammation associated with osteoarthritis in horses.

Dosage

Using strict aseptic technique, administer 1.5 mL BetaVet ® (9 mg total betamethasone) per joint by intra-articular injection. BetaVet ® may be administered concurrently in up to 2 joints per horse.

Limitations
Do not use in horses intended for human consumption.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
10 mg florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate per mL
Dogs
Indication
For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
Dosage
Administer one dose (1 tube) per affected ear(s) and repeat administration in 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
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
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, Restricted During Pregnancy • Horse, Restricted During Pregnancy • Horse, Not For Meat Production
Composition / specifications
Each milliliter of the suspension contains the equivalent of 5 milligrams of betamethasone as betamethasone dipropionate and 2 milligrams of betamethasone as betamethasone sodium phosphate.
Dogs
Indication
It is used as an aid in the control of pruritus associated with dermatoses.
Dosage
It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections.
Limitations
It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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.
Horses
Indication
It is used as an aid in the control of inflammation associated with various arthropathies.
Dosage
It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity should be preceded by withdrawal of synovial fluid.
Limitations
Not for use in horses intended for food. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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: Horse, Not For Meat Production
Composition / specifications
The drug is a sterile aqueous suspension and each cubic centimeter contains: 12 milligrams of betamethasone acetate (equivalent to 10.8 milligrams of betamethasone), 3.9 milligrams of betamethasone disodium phosphate (equivalent to 3 milligrams of betamethasone)
Horses
Indication
It is used or intended for use for the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints.
Dosage
Administer from 2.5 to 5 cubic centimeters per dose by intra-articular injection. Dose may be repeated when necessary depending upon the duration of relief obtained.
Limitations
Not for use in horses intended or food. For use only 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
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 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
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
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.

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

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

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

    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

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of otitis externa in dogs associated with susceptible strains of bacteria ( Staphylococcus pseudintermedius) and yeast ( Malassezia pachydermatis).
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of infected superficial lesions in dogs caused by 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
    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 infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for a new product formulation..
SPL Packages

FDA page: Open in Animal Drugs @ FDA

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

It is used or intended for use for the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints. For treatment of external eye infections and inflammation in dogs. For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Not for use in horses intended or food. For use only 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. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered 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.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Skin & allergy
Hair loss at application site (1) • Cat Application site pruritus (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Cat

Showing top 5 for Behavior.

Other
Head shake - ear disorder (1) • Dog Glucosuria (1) • Cat Falling (1) • Cat Facial paralysis (1) • Dog Eye redness (1) • Dog
Show more (23)
Eye irritation (1) • Dog Excessive ear wax (1) • Dog Elevated globulins (1) • Cat Elevated blood urea nitrogen (1) • Cat Elevated alanine aminotransferase (1) • Cat Ear pain (1) • Dog Ear infection NOS (1) • Dog Ear discharge (1) • Dog Ear canal erythema (1) • Dog Drooping eyelid (1) • Dog Depressed ocular reflex (1) • Dog Blinking (1) • Dog Application site ulcer (1) • Cat Application site self trauma (1) • Cat Application site scab (1) • Cat Application site fibrosis (1) • Cat Application site erythema (1) • Cat Application site dermatitis (1) • Cat Application site crust (1) • Cat Application site bleeding (1) • Cat Abscess NOS (1) • Cat Abnormal pupil light reflex (1) • Dog Abnormal cytology (1) • Cat

Showing top 5 for Other.

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', 'Poodle - Standard'], Male, 6 year • Drug: MSK, Gel, Auricular (Otic), Dose: 1 tube per animal • Reactions: Lack of efficacy - NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-037213
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Gel
  • Dose: 1 tube per animal
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Ongoing

Dog, Shepherd Dog - German, Male, 8 year, 23.13 kilogram • Drug: MSK, Gel, Topical • Reactions: Lack of efficacy - NOS, Ear canal erythema, Ear pain, Ear discharge • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-011509
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 23.130 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Gel
Reactions Reported:
Lack of efficacy - NOS Ear canal erythema Ear pain Ear discharge
Outcomes: Outcome Unknown

Dog, Crossbred Canine/dog, Male, 8.5 year • Drug: MSK, Gel, Unknown • Reactions: Lack of efficacy - NOS, Head shake - ear disorder, Eye redness, Ocular discharge, Behavioral disorder (unspecified)… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-007614
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.50 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Gel
Reactions Reported:
Lack of efficacy - NOS Head shake - ear disorder Eye redness Ocular discharge Behavioral disorder (unspecified) Eye irritation Not eating Heart murmur Tooth disorder Facial paralysis Impaired hearing Head tilt - neurological disorder Abnormal pupil light reflex Depressed ocular reflex Blinking Drooping eyelid Excessive ear wax Ear infection NOS Otitis NOS
Outcomes: Outcome Unknown

Dog, Shepherd Dog - German, Male, 1 year, 35.3 kilogram • Drug: MSK, Gel, Unknown • Reactions: Lack of efficacy (fungi) - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-059166
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 35.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Gel
Reactions Reported:
Lack of efficacy (fungi) - NOS
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Female, 13 year, 33.3 kilogram • Drug: MSK, Ointment, Auricular (Otic), Dose: 1 dose per other, Frequency: 12 per hour • Reactions: Loss of hearing • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2024-US-064354
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 33.300 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Ointment
  • Dose: 1 dose per other
  • Frequency: 12 per hour
Reactions Reported:
Loss of hearing
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

Cat, Domestic Mediumhair, Female, 3.5 year, 4.082 kilogram • Drug: MSK, Gel, Auricular (Otic) • Reactions: Unsteady walking (ataxia), Other ear disorder NOS, Ear canal erythema, Not eating, Vomiting… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2022-US-000703
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 3.50 Year
  • Weight: 4.082 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Gel
Reactions Reported:
Unsteady walking (ataxia) Other ear disorder NOS Ear canal erythema Not eating Vomiting Tympanic alteration Tympanic rupture Pain NOS
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 7 year, 6.35 kilogram • Drug: MSK, Subcutaneous, Dose: 1 dose per unknown, Frequency: 1 per day • Reactions: Inappropriate urination, Application site pruritus, Application site erythema, Hair loss at application site, Application site ulcer… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2020-US-055851
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 6.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Dose: 1 dose per unknown
  • Frequency: 1 per day
Reactions Reported:
Inappropriate urination Application site pruritus Application site erythema Hair loss at application site Application site ulcer Application site crust Application site bleeding Application site self trauma Abnormal cytology Application site scab Application site dermatitis Application site fibrosis Inappropriate elimination NOS
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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