FDA.reportPublic FDA data

MiconazoleShampoo

Manufacturer
Davis Manufacturing and Packaging Inc | Vanessa Solis
Effective date
2019-11-07
Label type
OTC ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:40:33

Label at a glance#

ProductDavis Miconazole
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Davis Miconazole Shampoo with 2% Miconazole Nitrate is specifically formulated for dermatological conditions associated with fungal infections such as ringworm, superficial skin infections caused by yeast and scaling due to seborrhea. Made with rich emollients, it penetrates the coat and skin and locks in needed moisture while helping to provide soothing relief. Davis Miconazole Shampoo is free from dyes and fragrances that could cause further irritation or reactions.

SPL UNCLASSIFIED SECTION

MADE IN THE USA

 Davis Manufacturing

541 Proctor Avenue

Scottdale, GA 30079

www.davismfg.com

Product No. MS12   Rev 0712

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Miconazole Nitrate 2.0% 

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Propylene Glycol, Lauramide DEA, Colloidal Oatmeal, Ethylene Glycol Monostearate, Aloe Vera, PEG Distearate, Methylchloroisothiazolinone (and) Methylisothiazolinone

INSTRUCTIONS FOR USE SECTION

DIRECTIONS FOR USE Wet coat thoroughly with warm water. Apply shampoo to head and ears, then lather. Do not get shampoo into eyes. Repeat procedure with neck, chest, middle and hindquarter, finishing with legs. Allow shampoo to soak in for 10 minutes. To prevent ingestion, do not allow animal to lick while bathing. Rinse thoroughly with water. Repeat twice weekly until symptoms subside, then weekly, or as directed by a veterinarian.

SPL UNCLASSIFIED SECTION

If desired follow the Davis Miconazole Shampoo bath with one using Davis Chlorhexidine Shampoo or make your own Miconazole/Chlorhexidine Shampoo by premixing Davis Miconazole shampoo and Davis Chlorhexidine Shampoo.

PRECAUTIONS SECTION

Precautions: Avoid contact with eyes and mucous membranes. If eye contact occurs or skin irritation develops, rinse thoroughly with water, discontinue use and immediately contact your veterinarian.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Davis Veterinary Products
Miconazole Shampoo
With 2% Miconazole Nitrate
For Dogs, Cats, Puppies and Kittens

Therapeutic formula includes Colloidal Oatmeal to soothe damaged skin while helping to relieve symptoms of fungal infections

1 Gallon (3.785 Liters)

MSGMSG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Davis Veterinary Products
Miconazole Shampoo
With 2% Miconazole Nitrate
For Dogs, Cats, Puppies and Kittens

Therapeutic formula includes Colloidal Oatmeal to soothe damaged skin while helping to relieve symptoms of fungal infections

MS12MS12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1944692miconazole nitrate 2 % Medicated ShampooPSN4
1944692miconazole nitrate 20 MG/ML Medicated ShampooSCD4
1944692miconazole nitrate 2 % Medicated ShampooSY4

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
62570-070-01Davis Miconazole3785 g in 1 BOTTLESHAMPOO37854
62570-070-12Davis Miconazole355 g in 1 BOTTLESHAMPOO3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62570-070DAVIS MICONAZOLE (MICONAZOLE NITRATE) SHAMPOO [DAVIS MANUFACTURING AND PACKAGING INC]42 package rows20191108_26715826-7c09-450a-831e-a028e91b79e7.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62570-07062570-070-12, 62570-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
OATMEAL8PI54V663YIACT
PROPYLENE GLYCOL 1,2-DISTEARATET65PN3O37HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
GLYCOL STEARATE0324G66D0EIACT
ALOE VERA LEAFZY81Z83H0XIACT

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.