Meds A-Z
Miconazole
Detailed information about Miconazole
Pet Owner Quick Guide
Start here: what this medicine is for, what it does, and when it's usually needed.
Usually used for:
For the treatment of otitis externa in dogs associated with susceptible strains of yeast Malassezia pachydermatis and bacteria Staphylococcus pseudintermedius ).
What it does:
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 inf...
When it's needed:
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 obs...
Call your vet sooner if you notice:
- 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.
Commonly reported reactions:
- (2 reports)
- (2 reports)
- (2 reports)
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?
Miconazole
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: MSK
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/141330 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200196 · 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.
- 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.
Most Reported Reactions
| Reaction | Cases | Species | Serious cases |
|---|---|---|---|
| 2 | Cat, Dog | 2 | |
| 2 | Cat, Dog | 1 | |
| 2 | Cat, Dog | 0 | |
| 1 | Dog | 1 | |
| 1 | Cat | 1 | |
| 1 | Dog | 1 | |
| 1 | Dog | 1 | |
| 1 | Cat | 0 |
Species coverage: Cat (17) Dog (15)
View detailed reaction table
| Reaction | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Dog | Serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Cat | Non-serious | - | 1 | |
| Dog | Non-serious | - | 1 | |
| Cat | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Dog | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - | |
| Cat | Unknown | - | - |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2024-US-041625
Storage & Handling
No storage/handling guidance is linked yet.
Documents
Official label facts are separated from secondary summaries.
Official documents: 10 • Secondary summaries: 0
- UCM287927.pdf · FOI
- Easotic® · SPL
- A200196_Org_8_4_1997.pdf · FOI
- Miconosol · SPL
- Conofite® Cream 2% · SPL
- Conofite® Lotion 1% · SPL
- ucm059295.pdf · FOI
- Priconazole™ Lotion 1% and Spray 1% · SPL
- UCM202424.pdf · FOI
- Surolan® · SPL
No source yet.
- 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/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/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
Promotional Materials (Marketing)
This content is marketing material and not clinical guidance.
No marketing assets are linked yet.
No source yet.
Technical appendix (vet reference)
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.
- Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Feb 16, 2026, 11:00 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 Feb 16, 2026, 11:00 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Feb 16, 2026, 11:04 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- 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)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| 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.
-
UCM287927.pdf
• FOI summary • Official
• May 14, 2024
FDA FOI summary for application 141330
-
A200196_Org_8_4_1997.pdf
• FOI summary • Official
• May 22, 2017
FDA FOI summary for application 200196
-
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 & Revision History
Every non-trivial field is expected to include provenance and update timestamps.
- 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)
- 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 |
|---|---|---|---|---|
|
Easotic®
RX
Gentamicin Sulfate Hydrocortisone aceponate Miconazole Nitrate
Otic Suspension
• Otic
|
Virbac AH, Inc. | NADA 141-330 | Approved | May 14, 2024 |
|
Miconosol
RX
Miconazole Nitrate
Lotion
• Topical
|
Med-Pharmex, Inc. | ANADA 200-196 | Approved | May 22, 2017 |
|
Conofite® Cream 2%
RX
Miconazole Nitrate
Cream
• Topical
|
Intervet, Inc. | NADA 95183 | Approved | Jun 1, 2016 |
|
Conofite® Lotion 1%
RX
Miconazole Nitrate
Solution
• Topical
|
Intervet, Inc. | NADA 95184 | Approved | Jun 1, 2016 |
|
Priconazole™ Lotion 1% and Spray 1%
RX
Miconazole Nitrate
Lotion
• Topical
|
First Priority, Inc. | ANADA 200-362 | Approved | Jun 1, 2016 |
|
Surolan®
RX
Miconazole Nitrate Polymyxin B Sulfate Prednisolone Acetate
Liquid (Suspension)
• Otic
|
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.
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
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).
- Easotic® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
Summary
For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.
- Miconosol (ZIP)
FDA page: Open in Animal Drugs @ FDA
- Conofite® Cream 2% (ZIP)
FDA page: Open in Animal Drugs @ FDA
- Conofite® Lotion 1% (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
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.
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM202424.pdf
Summary
For the treatment of canine otitis externa associated with susceptible strains of yeast ( Malassezia pachydermatis) and bacteria ( Staphylococcus pseudintermedius)
- 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
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.
Side Effects
No approved side-effect narrative is linked yet.
openFDA reaction signals are available for Dog 56 and Cat 26 (view top reported reactions).
Top Reported Reactions (openFDA)
Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).
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
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
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
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
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
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
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
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
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.