FDA.reportPublic FDA data

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

Manufacturer
Granules Pharmaceuticals Inc.
Effective date
2025-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:01

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

Cures most ■ Athlete’s foot (tinea pedis) ■ Jock itch (tinea cruris) ■ Ringworm (tinea corporis) Effectively 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...

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)
■ Ringworm (tinea corporis)

Effectively relieves
■ itching
■ cracking
■ burning
■ discomfort which can accompany these conditions.

Warnings

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 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

SPL UNCLASSIFIED SECTION

  • store between 15º-30ºC (59º-86ºF)

Inactive ingredient

INACTIVE INGREDIENT SECTION

polyethylene glycol

Questions or comments?

SPL UNCLASSIFIED SECTION

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

PRINCIPAL DISPLAY PANEL - Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70010- 229-54

Clotrimazole
(Topical Solution), USP

1%

Antifungal

For External use only,

not for Opthalmic use.

Keep this and all medications out

of the reach of children.

10 mL (1/3 fl oz)

clotrima-containerclotrima-container

PRINCIPAL DISPLAY PANEL - Container Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70010- 229-54

*Compare to the active ingredient in

Lotrimin ® AF

Athlete's Foot Solution

Clotrimazole

(Topical Solution),

USP

1%

Antifungal

• Relieves Itching & Burning

• Greaseless, Nonstanining

For External use only,

Not for Ophthalmic use.

Keep this and all medications

out of the reach of children.

10 mL (1/3 fl oz)

clotrima-cartonclotrima-carton

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
70010-229-54Clotrimazole10 mL in 1 BOTTLESOLUTION103

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
70010-22970010-229-54

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
POLYETHYLENE GLYCOL 400B697894SGQIACT
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
ClotrimazoleCLOTRIMAZOLEGranules Pharmaceuticals Inc.1280353c-9f96-557e-e063-6294a90a10f92025-06-30WarningsExact identifier
ndc (package): 70010-229-54
ndc (product): 70010-229
ndc11 (package): 70010022954
spl id: 38d13395-e424-5f95-e063-6294a90a3635
spl set id: 1280353c-9f96-557e-e063-6294a90a10f9

Reported adverse events (FAERS/openFDA)#

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