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Roxee Meds Catalog

Clotrimazole

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Cream Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Storefront facts
Catalog refreshed
May 5, 2026, 10:00 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

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

Safety reports
No safety reports linked
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openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

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

Sources:
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Clotrimazole

Clotrimazole

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

Both Cream Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

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

Clotrimazole

For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes. The drug is used for the treatment of canine otitis externa associated with yeast ( Malassezia pachydermatis , formerly Pityrosporum canis ), and/or bacteria susceptible to gentamicin. Species commonly shown: Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied.

Generic name
Clotrimazole
Brand names
Veltrim 1% Dermatologic Cream, Clotrimazole, Aardora Anti-Fungal Maximum Strength
Manufacturer
Multiple FDA labelers
Species
Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied
Dosage forms
Cream
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Veltrim 1% Dermatologic Cream Clotrimazole Aardora Anti-Fungal Maximum Strength
Dosage forms
Cream

Indications / Uses

For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes. The drug is used for the treatment of canine otitis externa associated with yeast ( Malassezia pachydermatis , formerly Pityrosporum canis ), and/or bacteria susceptible to gentamicin.

Warnings / Contraindications

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

  • Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Partial deafness, Drug administration duration too long.

FAQ

Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied

Yes. Roxee shows this as prescription-only.

Cream

Related Conditions

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:

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

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:

  • Wash hands thoroughly after use to avoid spread of infection
  • Install ointment twice daily into the ear canal
  • Therapy should continue for 7 consecutive days
  • Tympanic rupture (1 reports)
  • Twitching (1 reports)
  • Stumbling gait (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?
Major cautions & emergency warning signs

Side effects to monitor:

  • Wash hands thoroughly after use to avoid spread of infection
  • Install ointment twice daily into the ear canal
  • Therapy should continue for 7 consecutive days
  • Tympanic rupture
  • Twitching

Most reported reactions:

  • Tympanic rupture (1 reports)
  • Twitching (1 reports)
  • Stumbling gait (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

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA labelers
Form: Cream
Identifiers:
ANADA: 200229 ANADA: 200283 ANADA: 200287 ANADA: 200536 NADA: 116089 NADA: 140896 NADA: 141177 NDC Package: 0061-0387-01 NDC Package: 0061-0387-02 NDC Package: 0061-0387-03 NDC Package: 0061-0387-08 NDC Package: 0061-0387-17 NDC Package: 0061-1246-01 NDC Package: 0061-1246-02 NDC Package: 0061-1246-04 NDC Package: 0061-1246-05 NDC Package: 13985-701-07 NDC Package: 13985-701-15 NDC Package: 13985-701-21 NDC Package: 13985-701-30
Source metadata:

Warnings / Contraindications

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

  • High: Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

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

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

Tracked signals
29
Reported cases
28
Serious reports
9
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Diarrhea Skin & allergy (1) · Twitching Neurologic (1) · Neurological signs NOS Effectiveness (1) · Lack of efficacy - NOS Other (24) · Upper respiratory sounds, Unclassifiable adverse event, Tympanic rupture
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Skin & allergy 1 Dog 1
Other 1 Dog 1
Neurologic 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1

Species coverage: Cat (18) Dog (11)

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

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

3

FOI

11

Veltrim 1% Dermatologic Cream

SPL · SPL

Open original
FDA Structured Product Label

Veltrim 1% Dermatologic Cream

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

Sponsor
Elanco US Inc.
NADA
116-089
Status
RX
Form
Cream
Route
Topical
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each gram of cream contains 10 milligrams of clotrimazole.

Dogs

Indication
For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes.
Dosage
Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.
Limitations
Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Indication
For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes.
Dosage
Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.
Limitations
Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Clotrimazole SPL

SPL · Structured Product Label

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

Aardora Anti-Fungal Maximum Strength SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Aardora Anti-Fungal Maximum Strength. Use the source link for the full official labeling record.

A200229_Orig_4_4_1998.pdf

FOI · FOI summary

Open original

UCM061643.pdf

FOI · FOI summary

Open original

ucm117265.pdf

FOI · FOI summary

Open original

ucm117268.pdf

FOI · FOI summary

Open original

ucm117269.pdf

FOI · FOI summary

Open original

N140896_Org_6_9_1993.pdf

FOI · FOI summary

Open original

UCM504539.pdf

FOI · FOI summary

Open original

ucm061714.pdf

FOI · FOI summary

Open original

ucm061715.pdf

FOI · FOI summary

Open original

ucm061716.pdf

FOI · FOI summary

Open original

ucm061711.pdf

FOI · FOI summary

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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Aardora Anti-Fungal Maximum Strength Clotrimazole
Manufacturer mapping: Multiple FDA labelers
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Cream • Topical
Applications: NADA 116-089
NDC: Packages 17030-002-01 24909-806-10 • Products 17030 24909
Documents: • SPL: 1 • 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
Related conditions: Otitis Externa (Ear Infection)
Linked using: Usage_Inferred (0.78)
Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

Counseling and Monitoring Highlights

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

Owner-facing counseling points
  • Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Tympanic rupture (1) Twitching (1) Stumbling gait (1) Neurological signs NOS (1) Medication error NOS (1) Loss of vision (1) Loss of hearing (1) Balance impaired (1)

Identifiers & Packages

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

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

Enriched Documents

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

  • Clotrimazole SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Aardora Anti-Fungal Maximum Strength 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
  • ucm117265.pdf • FOI summary • Official • Dec. 3, 2025
    FDA FOI summary for application 141177
  • ucm117268.pdf • FOI summary • Official • Dec. 3, 2025
    FDA FOI summary for application 141177
  • ucm117269.pdf • FOI summary • Official • Dec. 3, 2025
    FDA FOI summary for application 141177
  • N140896_Org_6_9_1993.pdf • FOI summary • Official • May 17, 2017
    FDA FOI summary for application 140896
  • UCM504539.pdf • FOI summary • Official • Aug. 16, 2016
    FDA FOI summary for application 200536
  • ucm061714.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200287
  • ucm061715.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200287
  • ucm061716.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200287
  • ucm061711.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 200283

Data Sources & Change Log

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

Official 27 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Partial deafness, Drug administration duration too long. (Clinical, 2026-04-11)
  • contraindications: Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install oin… (Official, 2026-04-11)
  • contraindications: Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Install oin… (Official, 2026-02-12)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-05)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-03)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-02)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-29)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-28)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-27)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-26)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-25)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-04-22)
  • side_effects: Top reported reactions (openFDA): Temporary deafness, PR-EAR(S), LESION(S), Loss of hearing, Deafness, Partial deafness, Drug administration duration too long. (Official, 2026-02-12)
  • usage: For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsp… (Official, 2026-04-11)
  • usage: For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsp… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage 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
  • 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
Veltrim 1% Dermatologic Cream
RX
Clotrimazole
Cream • Topical
Label highlights
Official documents
Elanco US Inc. NADA 116-089 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 • Cat, No Use Class Stated Or Implied
Composition / specifications
Each gram of cream contains 10 milligrams of clotrimazole.
Dogs
Indication
For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes.
Dosage
Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.
Limitations
Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats
Indication
For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes.
Dosage
Apply 1/4-inch ribbon of cream per square inch of lesion once daily for 2 to 4 weeks.
Limitations
Wash hands thoroughly after use to avoid spread of infection. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of fungal infections of caused by Microsporum canis and Trichophyton mentagrophytes. For the treatment of fungal infections caused by Microsporum canis and Trichophyton mentagrophytes. The drug is used for the treatment of canine otitis externa associated with yeast ( Malassezia pachydermatis , formerly Pityrosporum canis ), and/or bacteria susceptible to gentamicin.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

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

Top Reported Reactions (openFDA)

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

Digestive
Vomiting (1) • Cat Diarrhea (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Twitching (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Neurological signs NOS (1) • Dog

Showing top 5 for Neurologic.

Effectiveness
Lack of efficacy - NOS (1) • Cat

Showing top 5 for Effectiveness.

Other
Upper respiratory sounds (1) • Cat Unclassifiable adverse event (1) • Cat Tympanic rupture (1) • Dog Stumbling gait (1) • Dog Polyuria (1) • Cat
Show more (19)
Polydipsia (1) • Cat Neutrophilia (1) • Cat Nasal discharge (1) • Cat Medication error NOS (1) • Dog Loss of vision (1) • Dog Loss of hearing (1) • Dog Hyperproteinaemia (1) • Cat Hyperglycaemia (1) • Cat Glucosuria (1) • Cat Elevated globulins (1) • Cat Elevated blood urea nitrogen (1) • Cat Elevated alanine aminotransferase (1) • Cat Drug administration duration too long (1) • Dog Deafness (1) • Dog Cough (1) • Cat Balance impaired (1) • Dog Abscess NOS (1) • Cat Abnormal menace reflex test (1) • Dog Abnormal breathing • 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.

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.