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Miconazole

Detailed information about Miconazole

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

Reviewed: Not available

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

Sources:

Pet Owner Quick Guide

Start here first for the simple next-step summary.

Used for:

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
  • wobbly/unsteady walking (1 reports)
  • Tremors (1 reports)
  • Mewing (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:

  • Unsteady walking (ataxia) (1 reports)
  • Tremors (1 reports)
  • Mewing (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

Miconazole

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: 13985-433-05 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
Source metadata:

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:

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
20
Reported cases
19
Serious reports
6
Species represented
2
Grouped by Body System
Digestive (2) · Vomiting, Loss of appetite Skin & allergy (2) · Itching, Alopecia NOS Neurologic (3) · Unsteady walking (ataxia), Tremors, Head tremor Other (13) · Vocalisation, Unclassifiable adverse event, Ulceration NOS
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Neurologic 1 Dog 1
Neurologic 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Neurologic 1 Dog 1
Other 1 Dog 1
Digestive 1 Dog 0
Other 1 Cat 0

Species coverage: Dog (10) Cat (10)

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

Documents

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

Owner handouts (0)
  • No owner handouts linked yet.
Official label / PI (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:
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 16 • Cat 9 • 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
Unsteady walking (ataxia) (1) Tremors (1) Mewing (1) Loss of hearing (1) Head tremor (1) Deafness (1) Vomiting (1) Vocalisation (1)

Identifiers & Packages

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

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: 13985-433-05 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 NDC Package: 17033-175-16 NDC Package: 17033-176-08 NDC Package: 17033-176-16
Package NDC Product NDC Form / Route Status
11695-6980-1 11695 -
11695-6980-2 11695 -
13985-432-30 13985 -
13985-433-05 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 -

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, Deafness, Lack of efficacy - NOS, Impaired hearing, Hearing decreased, Behavioural disorder NOS. (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
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.
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
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
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.

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
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
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.
Cats
Indication
Miconazole nitrate is an agent for topical treatment of infections in 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
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.

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 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).
Dogs
Indication
Miconazole nitrate is an agent for topical treatment of infections in dogs 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
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.
Cats
Indication
Miconazole nitrate is an agent for topical treatment of infections in 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
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.

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 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 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
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.
Dogs
Indication
Miconazole nitrate is an agent for topical treatment of infections in dogs 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
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.

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
  • Summary

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

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • 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

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • 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

FDA page: Open in Animal Drugs @ FDA

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

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

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.

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) • Dog Loss of appetite (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Itching (1) • Cat Alopecia NOS (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Tremors (1) • Dog Head tremor (1) • Dog

Showing top 5 for Neurologic.

Other
Vocalisation (1) • Cat Unclassifiable adverse event (1) • Cat Ulceration NOS (1) • Cat Squinting (1) • Dog Pinnae disorder (1) • Cat
Show more (8)
Other abnormal test result NOS (1) • Cat Mewing (1) • Cat Medication error NOS (1) • Dog Loss of hearing (1) • Dog Eye irritation (1) • Dog Deafness (1) • Dog Crust (1) • Cat Abnormal cytology • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, ['Retriever - Golden', 'Poodle (unspecified)'], Male, 3 year, 31.75 kilogram • Drug: MSK, Suspension, Intraocular • Reactions: Squinting, Eye irritation, Medication error NOS • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055998
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 31.750 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intraocular
  • Form: Suspension
Reactions Reported:
Squinting Eye irritation Medication error NOS
Outcomes: Ongoing

Dog, Terrier - West Highland White, Male, 12 year, 9.52 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 1 dose per animal • Reactions: Deafness • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055789
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 9.520 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 1 dose per animal
Reactions Reported:
Deafness
Outcomes: Ongoing

Cat, Domestic Shorthair, Male, 4 month, 2.72 kilogram • Drug: MSK, Topical • Reactions: Vomiting • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-055511
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.00 Month
  • Weight: 2.720 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
Reactions Reported:
Vomiting
Outcomes: Recovered/Normal

Dog, Pekingese, Male, 9 year, 3.17 kilogram • Drug: MSK, Suspension, Topical, Dose: 5 drops per animal, Frequency: 1 per day • Reactions: Unsteady walking (ataxia), Tremors, Head tremor, Loss of hearing • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-052802
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 9.00 Year
  • Weight: 3.170 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Topical
  • Form: Suspension
  • Dose: 5 drops per animal
  • Frequency: 1 per day
Reactions Reported:
Unsteady walking (ataxia) Tremors Head tremor Loss of hearing
Outcomes: Ongoing

Dog, Shepherd Dog - German, Male, 8.58 year, 46.62 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 5 drops per animal, Frequency: 12 per hour • Reactions: Vomiting, Loss of appetite • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-052712
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.58 Year
  • Weight: 46.620 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 5 drops per animal
  • Frequency: 12 per hour
Reactions Reported:
Vomiting Loss of appetite
Outcomes: Ongoing

Dog, Maltese, Female, 11 year, 5.35 kilogram • Drug: MSK, Suspension, Auricular (Otic), Frequency: 12 per hour • Reactions: Loss of hearing • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-052344
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.00 Year
  • Weight: 5.350 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Frequency: 12 per hour
Reactions Reported:
Loss of hearing
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Male, 14 year, 6.58 kilogram • Drug: MSK, Suspension, Auricular (Otic) • Reactions: Unsteady walking (ataxia), Vocalisation • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-050900
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.00 Year
  • Weight: 6.580 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
Reactions Reported:
Unsteady walking (ataxia) Vocalisation
Outcomes: Outcome Unknown

Cat, Domestic Shorthair, Female, 18 year, 3.68 kilogram • Drug: MSK, Suspension, Auricular (Otic), Dose: 5 drops per animal, Frequency: 12 per hour • Reactions: Mewing, Loss of hearing • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-031666
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Female
  • Age: 18.00 Year
  • Weight: 3.680 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Suspension
  • Dose: 5 drops per animal
  • Frequency: 12 per hour
Reactions Reported:
Mewing Loss of hearing
Outcomes: Ongoing

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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