Clotrimazole Cream-Antifungal

Manufacturer
Encube Ethicals, Inc. | Encube Ethicals Private Limited
Effective date
2025-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:36

Label at a glance#

ProductANTIFUNGAL
Active ingredientCLOTRIMAZOLE
Label structure13 sections

Dosage and administration

wash the affected area and dry thoroughly  apply a thin layer of the product over 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 daily for athlete's foot and ringworm, use daily for 4 weeks; for j...

Storage and handling

store at room temperature 20°C to 25°C (68°F to 77°F) before using any medication, read all label directions. Keep carton, It contains important information.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole, USP 1% 

PURPOSE

OTC - PURPOSE SECTION

Antifungal

USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only.

DO NOT USE

OTC - DO NOT USE SECTION

on children under 2 years of age, unless directed by a doctor.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

avoid contact with the eyes.

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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 (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • wash the affected area and dry thoroughly 
  • apply a thin layer of the product over 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 daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store at room temperature 20°C to 25°C (68°F to 77°F)
  • before using any medication, read all label directions. Keep carton, It contains important information.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

Call 1-833-285-4151

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 0.5 OZ (14 g)

carton 14 gmcarton 14 gm

Athlete's Foot Cream

Clotrimazole Cream USP, 1% (Antifungal)

NET WT. 1 OZ (28 g)

carton 28 gmcarton 28 gm

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
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-094-04ANTIFUNGAL1 in 1 CARTONCREAM12
21922-094-04ANTIFUNGAL14 g in 1 TUBECREAM142
21922-094-05ANTIFUNGAL1 in 1 CARTONCREAM12
21922-094-05ANTIFUNGAL28 g in 1 TUBECREAM282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-094-04GM - Gram21922-09413c92971-15bc-4ff1-abc6-10068e73b5fb12025-11-13
21922-094-05GM - Gram21922-094b10723ba-4f02-448b-ba85-7587d502c65b12025-11-13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21922-09421922-094-04, 21922-094-05

Ingredients#

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

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

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
ANTIFUNGALCLOTRIMAZOLEEncube Ethicals, Inc.afbc28f8-bb76-424d-9d73-136e6c283ead2025-09-04WarningsExact identifier
ndc (package): 21922-094-05
ndc (package): 21922-094-04
ndc (product): 21922-094
ndc11 (package): 21922009404
ndc11 (package): 21922009405
spl id: c9cf3a99-2b28-49c8-85f9-f693ca847074
spl set id: afbc28f8-bb76-424d-9d73-136e6c283ead

Reported adverse events (FAERS/openFDA)#

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