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Roxee Medication Guide

Miconazole Nitrate

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

Both Reference complete FDA data linked Rx required Lotion Multiple FDA sponsors Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

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

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 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
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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.
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Miconazole Nitrate

Miconazole Nitrate

Drug type: Generic ingredient • Generic profile • No FDA branded products linked

Both Lotion Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA sponsors

Medication Snapshot

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

Miconazole Nitrate

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 ). Species commonly shown: Both, Dog, Cat.

Generic name
Miconazole Nitrate
Brand names
Miconosol, Priconazole™ Lotion 1% and Spray 1%
Manufacturer
Multiple FDA sponsors
Species
Both, Dog, Cat
Dosage forms
Lotion
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Miconosol Priconazole™ Lotion 1% and Spray 1%
Dosage forms
Lotion

Indications / Uses

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 ).

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.

  • 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

Top reported reactions (openFDA): Loss of hearing, Lack of efficacy - NOS, Deafness, Vomiting, Lack of efficacy (bacteria) - NOS, Lethargy (see also Central nervous system depression in Neurological).

FAQ

Both, Dog, Cat

Yes. Roxee shows this as prescription-only.

Lotion

Related Conditions

Pica Otitis Externa (Ear Infection)

Source Transparency

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Pet Owner Quick Guide

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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 .

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:

  • 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)
  • Vomiting (1 reports)
  • Vestibular disorder NOS (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

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Research brief

Medication Research Insights

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

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Miconazole Nitrate; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2024-US-038267
Safety signal coverage Reported signals

26 tracked reaction signals; 24 reported cases; 15 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2024-US-038267
Interpretation guardrail Not causation

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

Evidence tension

Stronger signal Label / review

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

Source: openFDA case USA-USFDACVM-2024-US-038267
Weaker signal Reported data

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

Reaction signal map

Most reported reactions Top terms

Wobbliness (1 reports), Vomiting (1 reports), Vestibular disorder NOS (1 reports), Unable to stand (1 reports), Tympanic rupture (1 reports)

Body systems represented Signal grouping

Digestive (3), Skin & allergy (5), Effectiveness (2), Other (16)

Species and breed lens

Species represented in reports Species lens

Dog (14 reports), Cat (12 reports)

What your vet may verify

Fit for this patient Vet check

Verify whether Miconazole Nitrate fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

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

What to watch next

Watch list Owner-safe

Accurate diagnosis of infecting organism is essential, Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution, 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

Call sooner if Escalation

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

Bottom line: Use this Miconazole Nitrate brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2024-US-038267 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. FDA application profile · official_label · quick facts
  5. Medication usage source · fda_animal_drugs · quick facts
  6. FOI · document · documents
  7. SPL · document · documents
  8. FOI · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:07 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • 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)
  • Vomiting (1 reports)
  • Vestibular disorder NOS (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Cat, Dog
Indication / use
Miconazole nitrate is an agent for topical treatment of infections in dogs and cats caused by Microsporum canis, Microsporum gypseum , and Trichophyton mentagrophytes .
Form / route / dose
Form: Lotion
Route: Topical
Confirm product label and patient-specific plan.
Warnings
  • High: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected ti…
Adverse-event caveat
No stored openFDA case explorer rows are linked yet.
Source docs

Quick Facts

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

Species: Both
Manufacturer: Multiple FDA sponsors
Form: Lotion
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:

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
26
Reported cases
24
Serious reports
15
Species represented
2
Grouped by Body System
Digestive (3) · Vomiting, Diarrhea, Appetite loss Skin & allergy (5) · Localised rash, Hives, Hair loss Effectiveness (2) · Lack of efficacy - NOS, Lack of efficacy (fungi) - NOS Other (16) · Wobbliness, Vestibular disorder NOS, Unable to stand
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Digestive 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1

Species coverage: Dog (14) Cat (12)

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

Source Documents

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

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

Miconosol SPL · SPL Priconazole™ Lotion 1% and Spray 1% SPL · SPL A200196_Org_8_4_1997.pdf FOI · FOI

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

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

2

FOI

4

Miconosol

SPL · SPL

Open original
FDA Structured Product Label

Miconosol

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

Sponsor
Med-Pharmex, Inc.
ANADA
200-196
Status
RX
Form
Lotion
Route
Topical
Species
Dog • Cat
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.

Priconazole™ Lotion 1% and Spray 1%

SPL · SPL

Open original
FDA Structured Product Label

Priconazole™ Lotion 1% and Spray 1%

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

Sponsor
First Priority, Inc.
ANADA
200-362
Status
RX
Form
Lotion
Route
Topical
Species
Dog • Cat
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.

A200196_Org_8_4_1997.pdf

FOI · FOI

Open original

ucm059295.pdf

FOI · FOI

Open original

UCM287927.pdf

FOI · FOI summary

Open original

UCM202424.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
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:41 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.
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Catalog species: Both • FDA-labeled species: Cat, Dog
Rx/OTC: RX
Form/route: Lotion • Topical
Applications: ANADA 200-196 • ANADA 200-362
Documents: 2 (FOI: 2) • SPL: 2 • 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: Pica Otitis Externa (Ear Infection)
Linked using: Fda_Label (0.95), 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
  • 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) Vomiting (1) Vestibular disorder NOS (1) Unable to stand (1) Tympanic rupture (1) Tympanic alteration (1) TOXICITY (1) Throat irritation (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: 13985-447-08 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 NDC Package: 17033-178-07
Package NDC Product NDC Form / Route 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 75 Clinical 8 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 … (Clinical, 2026-04-15)
  • contraindications: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or … (Clinical, 2026-04-11)
  • 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… (Clinical, 2026-05-02)
  • 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… (Clinical, 2026-04-22)
  • 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… (Clinical, 2026-04-15)
  • 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… (Clinical, 2026-04-11)
  • usage: Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis , Microsporum gypseum , and Trichophyton mentagrophytes … (Clinical, 2026-04-15)
  • usage: Miconazole nitrate is an agent for topical treatment of infections in dogs caused by Microsporum canis , Microsporum gypseum , and Trichophyton mentagrophytes … (Clinical, 2026-04-11)
  • contraindications: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or … (Official, 2026-05-02)
  • contraindications: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or … (Official, 2026-04-30)
  • contraindications: Accurate diagnosis of infecting organism is essential. Identify by microscopic examination of a mounting of infected tissue in potassium hydroxide solution or … (Official, 2026-04-22)
  • 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)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-22)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-22)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-21)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-20)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-13)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-12)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-12)
  • indications: For the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes. PRICONAZOLE (miconazo… (Official, 2026-06-11)
Recent Revisions
  • side_effects updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-02 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:07 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-15 10:04 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • 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
Miconosol
RX
Miconazole Nitrate
Lotion • Topical
Label highlights
Official documents
Med-Pharmex, Inc. ANADA 200-196 W Feb 27, 2026
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

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 • Cat
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 • Cat
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

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 Diarrhea (1) • Cat Appetite loss (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Localised rash (1) • Dog Hives (1) • Dog Hair loss (1) • Cat Facial swelling (possible allergy) (1) • Dog 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 Tympanic rupture (1) • Dog Tympanic alteration (1) • Dog
Show more (11)
TOXICITY (1) • Cat Throat irritation (1) • Cat Sickness (1) • Cat Pinnal ulcer (1) • Dog Pain NOS (1) • Dog Loss of hearing (1) • Dog Erythema (1) • Cat Ear canal inflammation (1) • Dog Application site scratching (1) • Dog Blindness • 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.

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.

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