FDA.reportPublic FDA data

Clotrimazole Cream USP, 1% Athlete's Foot

Manufacturer
Wal-Mart Stores, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:06:43

Label at a glance#

ProductClotrimazole Athletes Foot
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 1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-812-01

equate™

Compare to
Lotrimin® AF
active
ingredient*

Ahtlete's
Foot

Clotrimazole USP 1%
Antifungal Cream

Cures most
athlete's foot

  • Relieves itching,
    burning, cracking
    & scaling

NET WT
0.5 OZ (14.2 g)

(CAP THIS END)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN5
309367clotrimazole 10 MG/ML Topical CreamSCD5
309367clotrimazole 1 % Topical CreamSY5

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-812-01ClotrimazoleAthletes Foot15 g in 1 TUBECREAM155
49035-812-01ClotrimazoleAthletes Foot1 in 1 CARTONCREAM15
49035-812-27ClotrimazoleAthletes Foot60 g in 1 TUBECREAM605
49035-812-27ClotrimazoleAthletes Foot1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-812-27GM - Gram49035-812b3bbda9c-5749-49cd-a09c-aace6be6431012015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H652
ClotrimazoleACTIVE MOIETYG07GZ97H652
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH2
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S2
cetyl esters waxINACTIVE INGREDIENTD072FFP9GU2
octyldodecanolINACTIVE INGREDIENT461N1O614Y2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-81249035-812-01, 49035-812-27

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 · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetyl esters waxCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetyl esters waxCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetyl esters waxCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 Athletes FootCLOTRIMAZOLEWal-Mart Stores, Inc.1440cf4d-e075-4137-a8ee-f41bd449c9982025-07-08WarningsExact identifier
ndc (package): 49035-812-01
ndc (package): 49035-812-27
ndc (product): 49035-812
ndc11 (package): 49035081227
ndc11 (package): 49035081201
spl id: 3970f9b7-3626-fd44-e063-6394a90aa09f
spl set id: 1440cf4d-e075-4137-a8ee-f41bd449c998

Reported adverse events (FAERS/openFDA)#

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