FDA.reportPublic FDA data

Miconazole

Manufacturer
GlenHaven LLC | Dechra Veterinary Products
Effective date
2021-12-07
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:41:10

Label at a glance#

ProductMiconazole
Active ingredientMiconazole Nitrate
Label structure9 sections

Storage and handling

STORAGE : Store at controlled room temperature of 20-25° C (68-77° F).

Label contents#

Full prescribing information#

VETERINARY INDICATIONS SECTION

Miconazole Shampoo is an antifungal shampoo which promotes healthy skin for animals with conditions responsive to miconazole. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

DESCRIPTION SECTION

ACTIVE INGREDIENT: 2% Miconazole Nitrate, USP

DESCRIPTION SECTION

ALSO CONTAINS: Water, Sodium C14-16 Alpha Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Laureth Sulfate, Glycol Stearate, Fragrance, Glycerine, Sodium Lactate, Tetrasodium EDTA, Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Carthamus Tinctorius (Safflower) Seed Oil, Citric Acid, Sodium Chloride, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Shake bottle before each use. After wetting or bathing your pet massage Miconazole Shampoo into your pet's wet coat until lightly lathered. Leave on pet for 5-10 minutes, then rinse thoroughly. Use initially 2-4 times per week for 4 weeks, then reduce to once per week or as directed by veterinarian. For best results follow with GlenHaven Miconazole Conditioner.

SAFE HANDLING WARNING SECTION

CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use or call your veterinarian. Keep out of reach of children and pets. Wash hands after use.

STORAGE AND HANDLING SECTION

STORAGE: Store at controlled room temperature of 20-25° C (68-77° F).

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Available through licensed veterinarians only.

SPL UNCLASSIFIED SECTION

Manufactured for:

GlenHaven
18101 SE 6th Way
Vancouver, WA 98683

53239 REV02/19

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70782-101-12

GlenHaven™
Therapeutics

Miconazole
Shampoo

Formerly F2/S

Antiseptic, antifungal

2% Miconazole Nitrate, USP

For Dog and Cat Use Only

Net Contents: 12 FL OZ. (355 mL)

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1944692miconazole nitrate 2 % Medicated ShampooPSN3
1944692miconazole nitrate 20 MG/ML Medicated ShampooSCD3
1944692miconazole nitrate 2 % Medicated ShampooSY3

DailyMed Pharmacologic Classes#

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

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
70782-101-12Miconazole355 mL in 1 BOTTLESHAMPOO3553

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70782-101MICONAZOLE (MICONAZOLE NITRATE) SHAMPOO [GLENHAVEN LLC]31 package rows20211208_abf63136-b58f-4bd7-966d-762c09d7b9bc.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70782-10170782-101-12

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

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.