FDA.reportPublic FDA data

Clotrimazole

Manufacturer
Walgreen Company | Sun Pharma Canada Inc.
Effective date
2025-07-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:07:03

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 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

To open: unscrew cap, use the pointed end of cap to puncture seal. 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%

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 productavoid 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

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT RD.,
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clotrimazole-01clotrimazole-01Athlete's Foot Cream
CLOTRIMAZOLE CREAM USP, 1% / ANTIFUNGAL

NET WT 1 OZ (28.4 g)

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2105-01Clotrimazole14.2 g in 1 TUBECREAM14.24
0363-2105-01Clotrimazole1 in 1 CARTONCREAM14
0363-2105-02Clotrimazole1 in 1 CARTONCREAM14
0363-2105-02Clotrimazole28.4 g in 1 TUBECREAM28.44

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-21050363-2105-01, 0363-2105-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
OCTYLDODECANOL461N1O614YIACT
POLYSORBATE 60CAL22UVI4MIACT
WATER059QF0KO0RIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
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
ClotrimazoleCLOTRIMAZOLEWalgreen Company5cc1c525-8ff2-429b-97ec-129e0100db472025-07-11WarningsExact identifier
ndc (package): 0363-2105-01
ndc (package): 0363-2105-02
ndc (product): 0363-2105
ndc11 (package): 00363210502
ndc11 (package): 00363210501
spl id: 39a8a783-62c4-36bc-e063-6394a90a795d
spl set id: 5cc1c525-8ff2-429b-97ec-129e0100db47

Reported adverse events (FAERS/openFDA)#

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