FDA.reportPublic FDA data

Clotrimazole

Manufacturer
Kareway Product, Inc.
Effective date
2023-02-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:09

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

wash affected area and dry thoroughly apply a thin layer cover affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for...

Storage and handling

store between 2°and 30° C (36° and 86° F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

WARNINGS SECTION

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)
  • do not use for diaper rash

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer cover affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
  • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • if conditions persist longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store between 2°and 30° C (36° and 86° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, sodium lauryl sulfate, stearic acid, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN4
309367clotrimazole 10 MG/ML Topical CreamSCD4
309367clotrimazole 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0638-12025-01-30C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole
67510-0638-12023-02-17C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole
67510-0638-12023-01-30C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole
67510-0638-12020-12-30C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole
67510-0638-12020-09-27C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole
67510-0638-12020-09-25C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole
67510-0638-12020-07-22C16284748780-1ab0e2407-2812-f274-e053-dbdaa90a6471Soundbody Clotrimazole

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0638-1Clotrimazole1 in 1 BOXCREAM14
67510-0638-1Clotrimazole28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0638CLOTRIMAZOLE CREAM [KAREWAY PRODUCT, INC.]4Legacy NDC, 2 package rows20230219_74793b07-9428-addc-e053-2a91aa0ae2b1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-063867510-0638-1

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
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERYL 1-STEARATE258491E1RZIACT
CARBOMER 9404Q93RCW27EIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLPARABEN14255EXE39IACT
STEARIC ACID4ELV7Z65APIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
WATER059QF0KO0RIACT

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4eec334-ed72-ea33-e053-2a95a90a12fd74793b07-9428-addc-e053-2a91aa0ae2b12023-02-17WarningsExact identifier
spl id: f4eec334-ed72-ea33-e053-2a95a90a12fd
spl set id: 74793b07-9428-addc-e053-2a91aa0ae2b1

Reported adverse events (FAERS/openFDA)#

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