FDA.reportPublic FDA data

Clotrimazole 1%

Manufacturer
GERI-GENTLE CORPORATION
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:29

Label at a glance#

ProductClotrimazole 1% Athletes Foot
Active ingredientCLOTRIMAZOLE
Label structure9 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 over affected area twice daily (morning and night) 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 socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if condition persists longe...

Storage and handling

store between 20° - 25°C (68° - 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1% (w/w)

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

For external use only

OTC - DO NOT USE SECTION

Do not useon children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with 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 or ringworm) or 2 weeks (for jock itch).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.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 over affected area twice daily (morning and night)
  • 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 socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store between 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceteth-20, Cetostearyl Alcohol, Chorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite,Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69771-032-232025-04-21C16284748780-11030e365-3833-111a-e063-dadaa90a10e2GG Clotrimazole USP, 1%
69771-032-232024-01-30C16284748780-11030e365-3833-111a-e063-dadaa90a10e2GG Clotrimazole USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-032-23Clotrimazole 1%Athletes Foot113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-032CLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [GERI-GENTLE CORPORATION]2Current NDC, Legacy NDC, 1 package rows20250423_e673748f-d00b-4ce8-e053-2995a90a9220.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-03269771-032-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM METABISULFITE4VON5FNS3CIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
CHLOROCRESOL36W53O7109IACT
LIGHT MINERAL OILN6K5787QVPIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
Clotrimazole 1% Athletes FootCLOTRIMAZOLEGERI-GENTLE CORPORATIONe673748f-d00b-4ce8-e053-2995a90a92202025-04-21WarningsExact identifier
ndc (package): 69771-032-23
ndc (product): 69771-032
ndc11 (package): 69771003223
spl id: 334f174d-fe88-517d-e063-6394a90a8d4d
spl set id: e673748f-d00b-4ce8-e053-2995a90a9220

Reported adverse events (FAERS/openFDA)#

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