FDA.reportPublic FDA data

Athlete's Foot Solution Clotrimazole Topical solution, USP 1%

Manufacturer
Granules USA, Inc.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:27:53

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure13 sections

Indications and uses

Cures most Athlete’s foot (tinea pedis), Jock itch (tinea cruris), and Ringworm (tinea corporis). Effective relieves • itching • cracking • burning • discomfort which can accompany these conditions

Dosage and administration

this product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. clean 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP, 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Cures most

  • Athlete’s foot (tinea pedis),
  • Jock itch (tinea cruris), and
  • Ringworm (tinea corporis).

Effective relieves

• itching

• cracking

• burning

• discomfort which can accompany these conditions

Warning

WARNINGS SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on children under 2 years of age

When using this product

OTC - WHEN USING SECTION

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 and ringworm) or 2 weeks (for jock itch)

Keep out of the 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

  • this product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
  • clean 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; change shoes and socks at least once daily

Other information

OTHER SAFETY INFORMATION

■ store between 15°-30°C (59°-86°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

polyethylene glycol 400.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

Clotrimazole 1% Topical Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 ml10 ml

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130813874020513GTIN-13: 0813874020513
EAN-13: 0813874020513
GTIN-12: 813874020513
UPC-A: 813874020513
GTIN storage (14 digits): 00813874020513		300000264_R-00_Final.jpg
Data codeData Matrix300000264300000264_R-00_Final.jpg
Data codeITF01023881300000264_R-00_Final.jpg

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
69848-001-01Clotrimazole10 mL in 1 BOTTLESOLUTION106

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69848-00169848-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
POLYETHYLENE GLYCOL 400B697894SGQIACT

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
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
ndc (package): 69848-001-01
ndc (product): 69848-001
ndc11 (package): 69848000101
spl id: 4690b8d8-7cc2-ebf2-e063-6294a90af113
spl set id: 6e63e29a-eb50-1790-e053-2a91aa0a3616

Reported adverse events (FAERS/openFDA)#

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