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Roxee Medication Guide

Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Ointment Merck Sharp & Dohme Corp. Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
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These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
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Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
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  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
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  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
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Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate

Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate

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

Both Ointment Rx required 100% reference complete

Species: Both

Manufacturer: Merck Sharp & Dohme Corp.

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate

For the treatment of acute and chronic canine otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis ) and/or bacteria susceptible to gentamicin. 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. Species commonly shown: Both, Dog, Restricted During Pregnancy.

Generic name
Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate
Brand names
Otomax®, Tri-Otic® Ointment, Vetro-Max®, GBC Ointment™
Manufacturer
Merck Sharp & Dohme Corp.
Species
Both, Dog
Dosage forms
Ointment
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Otomax® Tri-Otic® Ointment Vetro-Max® GBC Ointment™ Otomax
Dosage forms
Ointment

Indications / Uses

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

Warnings / Contraindications

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. 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.

  • 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. 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.

Side Effects

Top reported reactions (openFDA): Diarrhoea, Horizontal nystagmus, Lack of efficacy - NOS, Stumbling gait.

FAQ

Both, Dog, Restricted During Pregnancy

Yes. Roxee shows this as prescription-only.

Ointment

Related Conditions

Dystocia Metritis Otitis Externa (Ear Infection)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

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.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Install ointment twice daily into the ear canal
  • Therapy should continue for 7 consecutive days
  • 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
  • Stumbling gait (1 reports)
  • Lack of efficacy - NOS (1 reports)
  • Horizontal nystagmus (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 tell or 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?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2024-US-010569
Safety signal coverage Reported signals

4 tracked reaction signals; 4 reported cases; 1 species group. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2024-US-010569
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2024-US-010569
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Stumbling gait (1 reports), Lack of efficacy - NOS (1 reports), Horizontal nystagmus (1 reports), Diarrhea (1 reports)

Body systems represented Signal grouping

Digestive (1), Effectiveness (1), Other (2)

Species and breed lens

Species represented in reports Species lens

Dog (4 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Install ointment twice daily into the ear canal, Therapy should continue for 7 consecutive days, Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft p, Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported, Clinical and experimental data have demonstrated that corticosteroids administered orally or parente

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2024-US-010569 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. FOI · document · documents
  8. SPL · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:06 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Install ointment twice daily into the ear canal
  • Therapy should continue for 7 consecutive days
  • 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

Most reported reactions:

  • Stumbling gait (1 reports)
  • Lack of efficacy - NOS (1 reports)
  • Horizontal nystagmus (1 reports)

Emergency warning signs:

  • 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

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
The drug is used for the treatment of canine otitis externa associated with yeast ( Malassezia pachydermatis , formerly Pityrosporum canis ), and/or bacteria susceptible to gentam…
Form / route / dose
Form: Ointment
Route: Topical
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install ointment twice daily into…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Merck Sharp & Dohme Corp.
Form: Ointment
Identifiers:
ANADA: 200229 ANADA: 200283 ANADA: 200287 NADA: 140896 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 Product: 0061
Source metadata:

Warnings / Contraindications

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. 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.

  • High: 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. 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.
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
4
Reported cases
4
Serious reports
0
Species represented
1
Grouped by Body System
Digestive (1) · Diarrhea Effectiveness (1) · Lack of efficacy - NOS Other (2) · Stumbling gait, Horizontal nystagmus
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 0
Effectiveness 1 Dog 0
Other 1 Dog 0
Digestive 1 Dog 0

Species coverage: Dog (4)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Other Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Other Dog Non-serious - 1
Digestive Dog Non-serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

Tri-Otic® Ointment SPL · SPL Otomax® SPL · SPL GBC Ointment™ SPL · SPL

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

6

FOI

7

Tri-Otic® Ointment

SPL · SPL

Open original
FDA Structured Product Label

Tri-Otic® Ointment

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Med-Pharmex, Inc.
ANADA
200-229
Status
RX
Form
Ointment
Route
Topical
Species
Dog
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.

Otomax®

SPL · SPL

Open original
FDA Structured Product Label

Otomax®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Intervet, Inc.
NADA
140-896
Status
RX
Form
Ointment
Route
Topical
Species
Dog
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.

GBC Ointment™

SPL · SPL

Open original
FDA Structured Product Label

GBC Ointment™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-287
Status
RX
Form
Ointment
Route
Topical
Species
Dog
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.

Vetro-Max®

SPL · SPL

Open original
FDA Structured Product Label

Vetro-Max®

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Fougera Pharmaceuticals, Inc.
ANADA
200-283
Status
RX
Form
Ointment
Route
Topical
Species
Dog
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.

Otomax SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Otomax. Use the source link for the full official labeling record.

Otomax SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Otomax. Use the source link for the full official labeling record.

UCM061643.pdf

FOI · FOI

Open original

A200229_Orig_4_4_1998.pdf

FOI · FOI

Open original

N140896_Org_6_9_1993.pdf

FOI · FOI

Open original

ucm061716.pdf

FOI · FOI

Open original

ucm061715.pdf

FOI · FOI

Open original

ucm061714.pdf

FOI · FOI

Open original

ucm061711.pdf

FOI · FOI

Open original
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
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 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 Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Otomax
Manufacturer mapping: Merck Sharp & Dohme Corp.
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Ointment • Topical
Applications: ANADA 200-229 • NADA 140-896 • ANADA 200-287 • ANADA 200-283
NDC: Packages 0061-0387-01 0061-0387-02 0061-0387-03 0061-0387-08 0061-0387-17 • Products 0061
Documents: 7 (FOI: 7) • SPL: 4 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0 • View
Case summaries: 0
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
  • 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. 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. (Contraindication, High)
Top reaction signals
Stumbling gait (1) Lack of efficacy - NOS (1) Horizontal nystagmus (1) Diarrhea (1)

Identifiers & Packages

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

Identifiers
ANADA: 200229 ANADA: 200283 ANADA: 200287 NADA: 140896 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 Product: 0061
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 -

Enriched Documents

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

  • Otomax SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Otomax SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • 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
  • N140896_Org_6_9_1993.pdf • FOI summary • Official • May 17, 2017
    FDA FOI summary for application 140896
  • 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 & Change Log

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

Official 126 Clinical 3 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Diarrhoea, Horizontal nystagmus, Lack of efficacy - NOS, Stumbling gait. (Clinical, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Diarrhoea, Horizontal nystagmus, Lack of efficacy - NOS, Stumbling gait. (Clinical, 2026-04-15)
  • side_effects: Top reported reactions (openFDA): Diarrhoea, Horizontal nystagmus, Lack of efficacy - NOS, Stumbling gait. (Clinical, 2026-04-11)
  • contraindications: 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 … (Official, 2026-04-22)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-22)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-22)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-21)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-20)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-13)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-12)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-12)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-11)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-11)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-10)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-09)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-08)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-07)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-06)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-05)
  • indications: For the treatment of canine acute and chronic otitis externa associated with yeast ( Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria sus… (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects 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
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
Otomax®
RX
Betamethasone Valerate Clotrimazole Gentamicin Sulfate
Ointment • Topical
Label highlights
Official documents
Intervet, Inc. NADA 140-896 Approved May 17, 2017
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
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
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
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
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
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

Usage

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

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. 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.

Top Reported Reactions (openFDA)

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

Digestive
Diarrhea (1) • Dog

Showing top 5 for Digestive.

Effectiveness
Lack of efficacy - NOS (1) • Dog

Showing top 5 for Effectiveness.

Other
Stumbling gait (1) • Dog Horizontal nystagmus (1) • Dog

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.

No case-level openFDA reports are linked for this medication yet.

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.

Share Your Thoughts

Let others know your experience or advice regarding this medication.

This medication has not been reviewed by a veterinarian yet.