Miconazole nitrate

Manufacturer
Butler Animal health Supply, LLC dba Covetrus North America | FIRST PRIORITY INCORPORATED
Effective date
2026-02-23
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 02:46:29

Label at a glance#

ProductMiconazole nitrate 1%
Active ingredientMICONAZOLE NITRATE
Label structure19 sections

Dosage and administration

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide, or by culture on an appropriate medium. Spray affected areas from a distance of 2 to 4 inches to apply a light covering, once daily for 2 to 4 weeks. Do not allow pet to contact finished wood surfaces until pet is th...

Storage and handling

Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep container tightly closed when not in use.

Label contents#

Full prescribing information#

VETERINARY INDICATIONS SECTION

Lotion & Spray
Topical antifungal agent for dogs and cats

PRECAUTIONS SECTION

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Not for Use in Humans
Keep Out of Reach of Children

Approved by FDA under ANADA # 200-362

2 fl oz (60 mL)

4 fl oz (120 mL)

8 fl oz (240 mL)

Indications:

INDICATIONS & USAGE SECTION

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

Dosage:

DOSAGE & ADMINISTRATION SECTION

Apply a light covering to affected areas, once daily for 2 to 4 weeks. See accompanying literature for full directions.
Avoid contact with eyes, since irritation may result.
Wash hands thoroughly after administration to avoid spread of fungal infection.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

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Lot No. / Exp. Date

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate . . . . . . . . . . . . . . . . . 1.15%
(equivalent to 1% miconazole base by weight)

Storage:

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep container tightly closed when not in use.

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Reorder #014676    60 mL  AH-014676-L-04 REV: 0723

Reorder #014677 120 mL   AH-014677-L-04 REV: 0723

Reorder #014678​ 240 mL   AH-014678-L-04 REV: 0723


Questions? (855) 724-3461

Distributed by:
Covetrus® North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

Description:

DESCRIPTION SECTION

Miconazole nitrate 1% Lotion & Spray is a synthetic antifungal agent for use in dogs and cats. It contains: 1.15% miconazole nitrate (equivalent to 1% miconazole base by weight), polyethylene glycol 400, and ethyl alcohol 55%.

Indications:

INDICATIONS & USAGE SECTION

Miconazole nitrate 1% Lotion & Spray is indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Precautions:

PRECAUTIONS SECTION

In the event of sensitization or irritation due to Miconazole nitrate 1% Lotion & Spray, treatment should be discontinued. Avoid contact with eyes, since irritation may result. Wash hands thoroughly after administration to avoid spread of fungal infection.

Dosage and administration:

DOSAGE & ADMINISTRATION SECTION

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide, or by culture on an appropriate medium.

Spray:

DOSAGE FORMS & STRENGTHS SECTION

Spray affected areas from a distance of 2 to 4 inches to apply a light covering, once daily for 2 to 4 weeks. Do not allow pet to contact finished wood surfaces until pet is thoroughly dried.
Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. If no improvement is noticed within 2 weeks, diagnosis should be re-evaluated. Difficult cases may require treatment for 6 weeks.
General measures in regard to hygiene should be observed to control sources of infection or reinfection. Clipping of hair around and over the sites of infection should be done at the start of treatment and again as necessary.

Lotion:

DOSAGE FORMS & STRENGTHS SECTION

Apply a light covering of Miconazole nitrate 1% Lotion to affected areas, once daily, for 2 to 4 weeks. Application is best accomplished using a gauze pad or cotton swab.
Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. If no improvement is noticed within 2 weeks, diagnosis should be re-evaluated. Difficult cases may require treatment for 6 weeks.
General measures in regard to hygiene should be observed to control sources of infection or reinfection. Clipping of hair around and over the sites of infection should be done at the start of treatment and again as necessary.

How supplied:

HOW SUPPLIED SECTION

Miconazole nitrate 1% Lotion is available in 60 mL bottles with droppers.
Miconazole nitrate 1% Spray is available in 120 mL and 240 mL bottles with spray misters.

Caution:

PRECAUTIONS SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CONTACT INFORMATION:

ADVERSE REACTIONS SECTION

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Covetrus® at (855) 724-3461 or covetrus.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Distributed by:
Covetrus® North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

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Approved by FDA under ANADA # 200-362

60 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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120 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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240 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of front of container labelimage of front of container labelimage of back of container labelimage of back of container labelimage of inner case labelimage of inner case labelimage of master case labelimage of master case label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-2221-2Miconazole nitrate1%72 in 1 CASESPRAY7215
11695-2221-2Miconazole nitrate1%60 mL in 1 BOTTLE, DROPPERSPRAY6015
11695-2221-4Miconazole nitrate1%12 in 1 CASESPRAY1215
11695-2221-4Miconazole nitrate1%120 mL in 1 BOTTLE, SPRAYSPRAY12015
11695-2221-8Miconazole nitrate1%12 in 1 CASESPRAY1215
11695-2221-8Miconazole nitrate1%240 mL in 1 BOTTLE, SPRAYSPRAY24015

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11695-222111695-2221-2, 11695-2221-4, 11695-2221-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142026-01-29monthly-update2026-06-03 17:49:30

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FGPER ANTIFUNGALMICONAZOLE NITRATEGuangzhou ChuanMa International Trading Co.,Ltd.5ced6af9-f9c4-6e62-e063-6294a90a0e112026-10-03WarningsName fallback
generic name: MICONAZOLE NITRATE
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEWalgreens0d991104-df96-49b8-b146-67f47b5fcd202026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
ClaravieMICONAZOLE NITRATEGentell LLC596d590b-e7ff-4be3-e063-6294a90a871d2026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)0cef9212-201d-4fd2-8afb-ae06ea6b6ee42026-08-20WarningsName fallback
generic name: MICONAZOLE NITRATE
DG Health MiconazoleMICONAZOLE NITRATEDolgencorp Inc12a36975-ebfe-4fcb-a9de-981a213256322026-08-19WarningsName fallback
generic name: MICONAZOLE NITRATE
up and up miconazole 7MICONAZOLE NITRATETarget Corporationb6216f21-4af8-40ab-8151-a9367a42b82c2026-08-18WarningsName fallback
generic name: MICONAZOLE NITRATE
Folliculitis CreamMICONAZOLE NITRATEBeautivity LLC3155dd5e-621b-358e-e063-6294a90a90f82026-08-13WarningsName fallback
generic name: MICONAZOLE NITRATE
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32026-08-12WarningsName fallback
generic name: MICONAZOLE NITRATE
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2026-08-11WarningsName fallback
generic name: MICONAZOLE NITRATE
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202026-08-11WarningsName fallback
generic name: MICONAZOLE NITRATE
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsName fallback
generic name: MICONAZOLE NITRATE
MICONAZOLE 1MICONAZOLE NITRATESafewaybd756451-6f63-4475-9d9a-7fef6a9e5ebf2026-08-03WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 3 Walgreen CompanyMICONAZOLE NITRATEWALGREEN COMPANY32b373be-9c8e-49b0-a796-8d87f6a20cef2026-07-21WarningsName fallback
generic name: MICONAZOLE NITRATE
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.85a52081-d9cc-44f0-a8d3-851a45c4eb102026-07-08WarningsName fallback
generic name: MICONAZOLE NITRATE
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.99c66cbd-7063-4b4c-b827-4f2fcb6ed67f2026-07-08WarningsName fallback
generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.