Quality Choice Clotrimazole cream USP, 1%

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC
Effective date
2023-05-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:06

Label at a glance#

ProductClotrimazole 1%
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

Wash 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...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal Cream

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 right away.

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

For External Use Only

● Do not use on children under 2 years of age unless directed by a doctor.

● When using this product 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 or ringwork) or within 2 weeks (for jock itch).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

Other Information

STORAGE AND HANDLING SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

DISTRIBUTED BY: CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

This product is not manufactured or distributed by Bayer Consumer Care, Inc. owner of the registered trademark Lotrimin® AF

Product of PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clotrimazole cream 1ozclotrimazole cream 1oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN3
309367clotrimazole 10 MG/ML Topical CreamSCD3
309367clotrimazole 1 % Topical CreamSY3

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-690-01Clotrimazole 1%28.3 g in 1 TUBECREAM28.33
63868-690-01Clotrimazole 1%1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-690CLOTRIMAZOLE 1% (CLOTRIMAZOLE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]3Legacy NDC, 2 package rows20230526_acc2baee-5762-3239-e053-2995a90ac48c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-690-01GM - Gram63868-690767f5756-3ec4-4b05-b90d-8b016e45734512022-09-12

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
63868-69063868-690-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
fc8797f1-908b-accb-e053-6294a90a1649acc2baee-5762-3239-e053-2995a90ac48c2023-05-25WarningsExact identifier
spl id: fc8797f1-908b-accb-e053-6294a90a1649
spl set id: acc2baee-5762-3239-e053-2995a90ac48c

Reported adverse events (FAERS/openFDA)#

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