FDA.reportPublic FDA data

Major Clotrimazole

Manufacturer
A-S Medication Solutions
Effective date
2021-02-04
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-05-31 23:37:49

Label at a glance#

ProductMAJOR CLOTRIMAZOLE
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of this 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 the 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 week...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal Cream

Uses

INDICATIONS & USAGE SECTION

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this 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 the 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 conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Oder No. 100431

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0524

NDC: 50090-0524-0 14.17 g in a TUBE / 1 in a CARTON

CLOTRIMAZOLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN14
309367clotrimazole 10 MG/ML Topical CreamSCD14
309367clotrimazole 1 % Topical CreamSY14

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0524-02023-01-30C16284748780-1f386c649-9ece-0266-e053-dadaa90a7c1aMAJOR CLOTRIMAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0524-0MAJOR CLOTRIMAZOLE1 in 1 CARTONCREAM114
50090-0524-0MAJOR CLOTRIMAZOLE14.17 g in 1 TUBECREAM14.1714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0524MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [A-S MEDICATION SOLUTIONS]14Legacy NDC, 2 package rows20210206_71df6a5b-99a0-4ff1-96a5-1b71372d5ee4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7822-31GM - Gram0904-78224550ddd1-4c27-45ac-a609-7e213f99b25212013-08-02
0904-7822-36GM - Gram0904-7822fbe6bade-1447-4324-b21c-27f87754c0b212013-08-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-052450090-0524-0
0904-7822

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
BENZYL ALCOHOLLKG8494WBHIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTYLDODECANOL461N1O614YIACT
CETYL PALMITATE5ZA2S6B08XIACT

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
46c2dc26-30b0-4c21-9154-b032e4b8123071df6a5b-99a0-4ff1-96a5-1b71372d5ee42021-02-04WarningsExact identifier
spl id: 46c2dc26-30b0-4c21-9154-b032e4b81230
spl set id: 71df6a5b-99a0-4ff1-96a5-1b71372d5ee4

Reported adverse events (FAERS/openFDA)#

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