Clotrimazole cream USP, 1%

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:23

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure12 sections

Indications and uses

Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, burning, cracking, 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 20°-25°C (68°- 77°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. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

● Do not use on children under 2 years of age except under the advice of a doctor.

● For external use only

● 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).

If Pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If Pregnant or breastfeeding, ask a health professional before use.

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 20°-25°C (68°- 77°F)
  • Close cap tightly after use.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-296-9067 Mon-Fri 9AM - 5PM

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 Volvo Parkway, Chesapeake, VA. 23320

NOT SATISFIED?

Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

This product is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

family wellness clotrimazole 05ozfamily wellness clotrimazole 05oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN5
309367clotrimazole 10 MG/ML Topical CreamSCD5
309367clotrimazole 1 % Topical CreamSY5

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
69396-038-05Clotrimazole1 in 1 BOXCREAM15
69396-038-05Clotrimazole15 g in 1 TUBECREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-038CLOTRIMAZOLE (FAMILY WELLNESS CLOTRIMAZOLE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5Current NDC, Legacy NDC, 2 package rows20241215_915759af-0d7b-6a87-e053-2a95a90acbd6.zip

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
69396-03869396-038-05

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
ClotrimazoleFAMILY WELLNESS CLOTRIMAZOLETrifecta Pharmaceuticals USA LLC915759af-0d7b-6a87-e053-2a95a90acbd62024-12-13WarningsExact identifier
ndc (package): 69396-038-05
ndc (product): 69396-038
ndc11 (package): 69396003805
spl id: 292a513a-420c-4ed2-e063-6294a90acae3
spl set id: 915759af-0d7b-6a87-e053-2a95a90acbd6

Reported adverse events (FAERS/openFDA)#

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