Meds A-Z

Miconazole Nitrate

Detailed information about Miconazole Nitrate

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:

FDA application profile · official_label
FDA application profile · official_label
Medication usage source · fda_animal_drugs
Conofite® Cream 2% · official_label
openFDA case USA-USFDACVM-2024-US-038267 · adverse_reaction

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

Miconazole nitrate is an agent for topical treatment of infections in dogs and cats caused by Microsporum canis, Microsporum gypseum , and Trichophyton mentagrophytes .

What to watch for:

Accurate diagnosis of infecting organism is essential
Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or by culture on an appropriate medium
If no improvement is observed in 2 weeks, reevaluate diagnosis and therapy
Avoid contact with eyes since irritation may result
For otic use in dogs only
Do not administer orally
Do not use in dogs with known perforated tympanum
Do not use with drugs known to induce ototoxicity
Do not use in dogs with known tympanic membrane perforation
Wobbliness (1 reports)
Vestibular disorder NOS (1 reports)
Unable to stand (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:

Accurate diagnosis of infecting organism is essential
Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or by culture on an appropriate medium
If no improvement is observed in 2 weeks, reevaluate diagnosis and therapy
Avoid contact with eyes since irritation may result
For otic use in dogs only

Most reported reactions:

Wobbliness (1 reports)
Vestibular disorder NOS (1 reports)
Unable to stand (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, 10:04 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 Mar 21, 2026, 10:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

Image coming soon

Miconazole Nitrate

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

Species: Both

Manufacturer: Not available (source)

Quick Facts

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

Species: Both

Manufacturer: Not available

Form: Cream, Liquid (Suspension), Lotion, Otic Suspension, Solution

Identifiers:

ANADA: 200196 ANADA: 200362 NADA: 141298 NADA: 141330 NADA: 95183 NADA: 95184 NDC Package: 11695-6980-1 NDC Package: 11695-6980-2 NDC Package: 13985-432-30 NDC Package: 13985-447-08 NDC Package: 13985-447-16 NDC Package: 17030-013-08 NDC Package: 17030-013-10 NDC Package: 17030-013-16 NDC Package: 17033-173-01 NDC Package: 17033-173-08 NDC Package: 17033-173-16 NDC Package: 17033-174-07 NDC Package: 17033-175-01 NDC Package: 17033-175-08

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200196 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141330 · official_label · FDA application profile
https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source

Warnings / Contraindications

Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or by culture on an appropriate medium. If no improvement is observed in 2 weeks, reevaluate diagnosis and therapy. Avoid contact with eyes since irritation may result. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

High: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or by culture on an appropriate medium. If no improvement is observed in 2 weeks, reevaluate diagnosis and therapy. Avoid contact with eyes since irritation may result. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation.

Source metadata:

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

Adverse Reactions

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

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

Tracked signals

Reported cases

Serious reports

Species represented

Grouped by Body System

Digestive (5) · Vomiting, Diarrhea, Appetite loss Skin & allergy (5) · Localised rash, Hives, Hair loss Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (fungi) - NOS Other (11) · Wobbliness, Vestibular disorder NOS, Unable to stand

Most Reported Reactions

Body system	Cases	Species	Serious cases
Other	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Cat	1
Other	1	Dog	1
Other	1	Dog	1
Skin & allergy	1	Dog	1

Species coverage: Cat (15) Dog (8)

View detailed reaction table

Body system	Species	Seriousness	Frequency	Reports
Other	Cat	Serious	-	1
Digestive	Cat	Non-serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Serious	-	1
Other	Cat	Non-serious	-	1
Other	Dog	Serious	-	1
Other	Dog	Serious	-	1
Skin & allergy	Dog	Serious	-	1
Effectiveness	Dog	Non-serious	-	1
Effectiveness	Cat	Non-serious	-	1
Skin & allergy	Dog	Serious	-	1
Skin & allergy	Cat	Non-serious	-	1
Other	Cat	Non-serious	-	1
Digestive	Cat	Non-serious	-	1
Skin & allergy	Dog	Non-serious	-	1
Other	Dog	Non-serious	-	1
Digestive	Cat	Non-serious	-	1
Skin & allergy	Dog	Unknown	-	-
Digestive	Cat	Unknown	-	-
Digestive	Cat	Unknown	-	-
Other	Cat	Unknown	-	-

Source metadata:

https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2024-US-038267

Documents

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

Owner handouts (0)

No owner handouts linked yet.

Official label / PI (0)

No official label or package insert links yet.

SPL (6)

Miconosol · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/327/Miconosol
Easotic® · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2210/Easotic%C2%AE
Conofite® Cream 2% · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1285/Conofite%C2%AE%20Cream%202%25
Conofite® Lotion 1% · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1293/Conofite%C2%AE%20Lotion%201%25
Priconazole™ Lotion 1% and Spray 1% · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/102/Priconazole%E2%84%A2%20Lotion%201%25%20and%20Spray%201%25
Surolan® · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2231/Surolan%C2%AE

FOI (4)

A200196_Org_8_4_1997.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1427
UCM287927.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/889
ucm059295.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1116
UCM202424.pdf · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/862

Source metadata:

https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1427 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/327/Miconosol · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/889 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2210/Easotic%C2%AE · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1285/Conofite%C2%AE%20Cream%202%25 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1293/Conofite%C2%AE%20Lotion%201%25 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1116 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/102/Priconazole%E2%84%A2%20Lotion%201%25%20and%20Spray%201%25 · document · SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/862 · document · FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/2231/Surolan%C2%AE · document · SPL

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 Mar 21, 2026, 10:04 AM UTC
openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC

Official (FDA)

Identity: Generic ingredient • FDA branded products available

Official FDA brands: Conofite® Cream 2% Conofite® Lotion 1% Easotic® Miconosol Priconazole™ Lotion 1% and Spray 1% Surolan®

Case-reported brands (openFDA): MSK

Catalog species: Both • FDA-labeled species: Cat, Dog

Rx/OTC: RX

Form/route: Cream, Liquid (Suspension), Lotion, Otic Suspension, Solution • Otic, Topical

Applications: ANADA 200-196 • NADA 141-330 • NADA 95183 • NADA 95184 • ANADA 200-362 • NADA 141-298

Documents: 4 (FOI: 4) • SPL: 6 • Label highlights • Official documents

Safety (openFDA)

Top reactions: Dog 14 • Cat 11 • View

Case summaries: 10 (showing 8) • View

openFDA reports are unverified and do not prove causation.

Explore

Related conditions: Otitis Externa (Ear Infection) Pica

Linked using: 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

Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or by culture on an appropriate medium. If no improvement is observed in 2 weeks, reevaluate diagnosis and therapy. Avoid contact with eyes since irritation may result. Federal law restricts this drug to use by or on the order of a licensed veterinarian. For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. 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. For Otic Use in Dogs Only. Do not use in dogs with known tympanic membrane perforation. (Contraindication, High)

Top reaction signals

Wobbliness (1) Vestibular disorder NOS (1) Unable to stand (1) TOXICITY (1) Throat irritation (1) Pinnal ulcer (1) Loss of hearing (1) Localised rash (1)

Identifiers & Packages

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

Identifiers

Package NDC	Product NDC	Status
11695-6980-1	11695	-
11695-6980-2	11695	-
13985-432-30	13985	-
13985-447-08	13985	-
13985-447-16	13985	-
17030-013-08	17030	-
17030-013-10	17030	-
17030-013-16	17030	-
17033-173-01	17033	-
17033-173-08	17033	-
17033-173-16	17033	-
17033-174-07	17033	-
17033-175-01	17033	-
17033-175-08	17033	-
17033-175-16	17033	-
17033-176-08	17033	-
17033-176-16	17033	-
17033-178-07	17033	-
17033-179-50	17033	-
17033-180-08	17033	-

Enriched Documents

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

A200196_Org_8_4_1997.pdf • FOI summary • Official • Feb. 27, 2026
FDA FOI summary for application 200196
UCM287927.pdf • FOI summary • Official • May 14, 2024
FDA FOI summary for application 141330
ucm059295.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 200362
UCM202424.pdf • FOI summary • Official • June 1, 2016
FDA FOI summary for application 141298

Data Sources & Change Log

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

Official 7 Clinical 0 Manufacturer 0 Marketing 0

Current Field Facts

contraindications: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or … (Official, 2026-02-12)
side_effects: Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Vomiting, Lack of efficacy (bacteria) - NOS, Lethargy (see also Central ne… (Official, 2026-02-12)
usage: Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis , Microsporum gypseum , and Trichophyton mentagrophytes … (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
Miconosol RX Miconazole Nitrate Lotion • Topical Label highlights Official documents	Med-Pharmex, Inc.	ANADA 200-196	W	Feb 27, 2026
Easotic® RX Gentamicin Sulfate Hydrocortisone aceponate Miconazole Nitrate Otic Suspension • Otic Label highlights Official documents	Virbac AH, Inc.	NADA 141-330	Approved	May 14, 2024
Conofite® Cream 2% RX Miconazole Nitrate Cream • Topical Label highlights Official documents	Intervet, Inc.	NADA 95183	Approved	Jun 1, 2016
Conofite® Lotion 1% RX Miconazole Nitrate Solution • Topical Label highlights Official documents	Intervet, Inc.	NADA 95184	Approved	Jun 1, 2016
Priconazole™ Lotion 1% and Spray 1% RX Miconazole Nitrate Lotion • Topical Label highlights Official documents	First Priority, Inc.	ANADA 200-362	Approved	Jun 1, 2016
Surolan® RX Miconazole Nitrate Polymyxin B Sulfate Prednisolone Acetate Liquid (Suspension) • Otic Label highlights Official documents	Elanco US Inc.	NADA 141-298	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

The lotion contains 1.15 percent of miconazole nitrate (equivalent to 1 percent miconazole base). The spray product consists of a dispensing container, sprayer pump assembly and lotion which contains 1.15 percent of miconazole nitrate (equivalent to 1-percent miconazole base).

Cats

Indication

Miconazole nitrate is an agent for topical treatment of infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Dosage

Apply once daily by rubbing into or spraying a light covering on the infected site and the immediate surrounding vicinity. Continue treatment for 2 to 4 weeks until infection is completely eradicated as determined by appropriate laboratory examination.

Limitations

Dogs

Indication

Miconazole nitrate is an agent for topical treatment of infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

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

Dogs

Indication

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

Dosage

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

Limitations

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

FDA page: Open in Animal Drugs @ FDA

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

Composition / specifications

The cream contains 23 milligrams of miconazole nitrate (equivalent to 20 milligrams of miconazole base) per gram.

Dogs

Indication

Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Dosage

Limitations

Cats

Indication

Miconazole nitrate is an agent for topical treatment of infections in cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

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

Dogs

Indication

Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Dosage

Limitations

Cats

Indication

Miconazole nitrate is an agent for topical treatment of infections in cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

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

Cats

Indication

Miconazole nitrate is an agent for topical treatment of infections in cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Dosage

Limitations

Dogs

Indication

Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes

Dosage

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied

Composition / specifications

23 mg/mL miconazole nitrate, 0.5293 mg/mL polymyxin B sulfate, 5 mg/mL prednisolone acetate

Dogs

Indication

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

Dosage

Instill 5 drops in the ear canal twice daily and massage the ear. Therapy should continue for 7 consecutive days.

Limitations

For otic use in dogs only. Do not administer orally. Do not use in dogs with known perforated tympanum. Do not use with drugs known to induce ototoxicity. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

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

Documents

FOI A200196_Org_8_4_1997.pdf

Summary

For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.

SPL Packages

Miconosol (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM287927.pdf

Summary

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

SPL Packages

Easotic® (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Conofite® Cream 2% (ZIP)

FDA page: Open in Animal Drugs @ FDA

SPL Packages

Conofite® Lotion 1% (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI ucm059295.pdf

Summary

PRICONAZOLE (miconazole nitrate) Lotion, 1% and Spray, 1% are indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

SPL Packages

Priconazole™ Lotion 1% and Spray 1% (ZIP)

FDA page: Open in Animal Drugs @ FDA

Documents

FOI UCM202424.pdf

Summary

For the treatment of canine otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius)

SPL Packages

Surolan® (ZIP)

FDA page: Open in Animal Drugs @ FDA

Usage

Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis , Microsporum gypseum , and Trichophyton mentagrophytes . Miconazole nitrate is an agent for topical treatment of infections in cats caused by Microsporum canis , Microsporum gypseum , and Trichophyton mentagrophytes . For the treatment of canine otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis ) and bacteria ( Staphylococcus pseudintermedius ).

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

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 Appetite loss (1) • Cat Bloody diarrhoea • Cat Blood in vomit • Cat

Showing top 5 for Digestive.

Skin & allergy

Localised rash (1) • Dog Hives (1) • Dog Hair loss (1) • Cat Chewing - pruritus (1) • Dog

Showing top 5 for Skin & allergy.

Effectiveness

Lack of efficacy - NOS (1) • Dog Lack of efficacy (fungi) - NOS (1) • Cat

Showing top 5 for Effectiveness.

Other

Wobbliness (1) • Cat Vestibular disorder NOS (1) • Cat Unable to stand (1) • Cat TOXICITY (1) • Cat Throat irritation (1) • Cat

Show more (6)

Sickness (1) • Cat Pinnal ulcer (1) • Dog Loss of hearing (1) • Dog Erythema (1) • Cat Application site scratching (1) • Dog Abnormal radiograph finding • 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, ['Pit Bull', 'Dog (unknown)'], Male, 7 year, 20.865 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per dose, Frequency: 1 per day • Reactions: Loss of hearing • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-055761
Serious AE: Yes
Treated For AE: No
Sex: Male
Age: 7.00 Year
Weight: 20.865 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension
Dose: 1 dose per dose
Frequency: 1 per day

Reactions Reported:

Loss of hearing

Outcomes: Outcome Unknown

Dog, Terrier (unspecified), Female, 14 year, 6.985 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Loss of hearing • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-055553
Serious AE: Yes
Treated For AE: No
Sex: Female
Age: 14.00 Year
Weight: 6.985 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension
Dose: 1 Other per dose
Frequency: 1 per day

Reactions Reported:

Loss of hearing

Outcomes: Outcome Unknown

Dog, Chihuahua, Female, 1.5 year, 5.443 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Chewing - pruritus, Application site scratching, Lack of efficacy - NOS • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2025-US-055857
Serious AE: No
Treated For AE: No
Sex: Female
Age: 1.50 Year
Weight: 5.443 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension
Dose: 1 dose per animal
Frequency: 1 per day

Reactions Reported:

Chewing - pruritus Application site scratching Lack of efficacy - NOS

Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 1.7 year, 18.688 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal, Frequency: 1 per day • Reactions: Hives, Localised rash • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-054269
Serious AE: Yes
Treated For AE: Yes
Sex: Male
Age: 1.70 Year
Weight: 18.688 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension
Dose: 1 dose per animal
Frequency: 1 per day

Reactions Reported:

Hives Localised rash

Outcomes: Recovered/Normal

Dog, Shih Tzu, Female, 8 year, 4.627 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 Other per dose, Frequency: 1 per day • Reactions: Pinnal ulcer • Outcome: Recovered/Normal

Report ID: USA-USFDACVM-2025-US-052998
Serious AE: Yes
Treated For AE: No
Sex: Female
Age: 8.00 Year
Weight: 4.627 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension
Dose: 1 Other per dose
Frequency: 1 per day

Reactions Reported:

Pinnal ulcer

Outcomes: Recovered/Normal

Cat, Domestic Longhair, Female, 4 month, 2.56 kilogram • Drug: MSK, Topical • Reactions: Appetite loss, Sickness, Diarrhea, Vomiting • Outcome: Ongoing

Report ID: USA-USFDACVM-2025-US-051651
Serious AE: No
Treated For AE: No
Sex: Female
Age: 4.00 Month
Weight: 2.560 Kilogram

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

Reactions Reported:

Appetite loss Sickness Diarrhea Vomiting

Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 4 year, 6.804 kilogram • Drug: MSK, Shampoo, Topical, Dose: 5 mL per dose • Reactions: Hair loss, Erythema • Outcome: Ongoing

Report ID: USA-USFDACVM-2024-US-038267
Serious AE: No
Treated For AE: Yes
Sex: Male
Age: 4.00 Year
Weight: 6.804 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Topical
Form: Shampoo
Dose: 5 mL per dose

Reactions Reported:

Hair loss Erythema

Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 6.1 year, 8.21 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 mL per dose, Frequency: 1 per day • Reactions: Vestibular disorder NOS, Unable to stand, Wobbliness • Outcome: Outcome Unknown

Report ID: USA-USFDACVM-2024-US-035205
Serious AE: Yes
Treated For AE: No
Sex: Female
Age: 6.10 Year
Weight: 8.210 Kilogram

Case-reported brand: MSK
Case-reported manufacturer: MSK
Route: Auricular (Otic)
Form: Suspension
Dose: 1 mL per dose
Frequency: 1 per day

Reactions Reported:

Vestibular disorder NOS Unable to stand Wobbliness

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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