FDA.reportPublic FDA data

CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%

Manufacturer
GRAXCELL PHARMACEUTICAL, LLC.
Effective date
2025-12-25
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 01:28:42

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 in the ...

Storage and handling

Store at 15°to 30°C (59° to 86°F)

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

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctorif

  • 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

STORAGE AND HANDLING SECTION

  • Store at 15°to 30°C (59° to 86°F)

inactive ingredients

INACTIVE INGREDIENT SECTION

polyethylene glycol 400

questions?

OTC - QUESTIONS SECTION

please call 1-888-266-8818

PRINCIPAL DISPLAY PANEL-10ML BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70795-8020-1

GRAXCELL PHARMACEUTICAL, LLC.

Compare to the active ingredient of Lotrimin®AF*

10ML Bottle

Clotrimazole (Topical Solution) USP,1%

Antifungal

Relieves Itching & Burning

  • Greaseless
  • Non-staining

For External use only.
Not for Opthalmic use.

Keep this and all medications out of the reach of children.

jpgjpg

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-130370795802012GTIN-13: 0370795802012
EAN-13: 0370795802012
GTIN-12: 370795802012
UPC-A: 370795802012
GTIN storage (14 digits): 00370795802012		Graxcell clotrimazole carton 10mL.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70795-8020-12025-12-25C16284748780-11030e365-413c-111a-e063-dadaa90a10e2CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%
70795-8020-12024-01-30C16284748780-11030e365-413c-111a-e063-dadaa90a10e2CLOTRIMAZOLE (TOPICAL SOLUTION) USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-8020-1CLOTRIMAZOLE10 mL in 1 BOTTLESOLUTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-8020-1ML - Milliliter70795-80204d046d82-f5ce-4b9e-a6c6-b9bb0513c4ef12019-02-13

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
70795-802070795-8020-1

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
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
ndc (package): 70795-8020-1
ndc (product): 70795-8020
ndc11 (package): 70795802001
spl id: 46d03d44-41ab-379e-e063-6394a90ab45d
spl set id: 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99

Reported adverse events (FAERS/openFDA)#

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