FDA.reportPublic FDA data

Leader Clotrimazole 1% antifungal Athlete's Foot Cream

Manufacturer
Cardinal Health 110 dba LEADER | Trifecta Pharmaceuticals USA
Effective date
2024-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:05

Label at a glance#

ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure14 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 accompany these conditions.

Dosage and administration

Wash the affected area and dry thoroughly. ● Apply a thin layer oover 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 j...

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%

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, burning, cracking, scaling and discomfort which accompany these conditions.

Warnings

WARNINGS SECTION

For External use only.

Keep this and all drugs out of the reach of children

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 (1-800-222-1222) right away.

Do Not Use

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless direcgted by a doctor

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

  • irritaion occurs
  • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area and dry thoroughly.

● Apply a thin layer oover 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Dimethyl Sulfoxide, Ethylparaben, Glycerol, Polyoxyethylene lauryl ether, Mineral Oil, Petrolatum, Water, alcohol, Mono and di-glycerides, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call 1-888-296-9067

Distributed by Cardinal Health

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

* This product is not manufactured or distributed by Schering-Plough, Inc., the distributor of Lotrimin®AF.

©2024 Cardinal Health. All rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

CIN 5888649

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5888649 Leader Clotrimazole Cream 1 percent 1oz rev1_24 042924 CDER5888649 Leader Clotrimazole Cream 1 percent 1oz rev1_24 042924 CDER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5888656 Leader Clotrimazole Cream 1 percent 9.5oz Rev1_24 042924 CDER5888656 Leader Clotrimazole Cream 1 percent 9.5oz Rev1_24 042924 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

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
70000-0667-1Clotrimazole1 in 1 BOXCREAM11
70000-0667-1Clotrimazole28 g in 1 TUBECREAM281
70000-0667-2Clotrimazole1 in 1 BOXCREAM11
70000-0667-2Clotrimazole14 g in 1 TUBECREAM141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0667CLOTRIMAZOLE CREAM [CARDINAL HEALTH 110 DBA LEADER]1Current NDC, 4 package rows20240531_199df107-3384-6e03-e063-6294a90afc38.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-066770000-0667-2, 70000-0667-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
LAURETH-23N72LMW566GIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONO AND DIPALMITOSTEARATEKC98RO82HJIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALCOHOL3K9958V90MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
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
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
ndc (package): 70000-0667-1
ndc (package): 70000-0667-2
ndc (product): 70000-0667
ndc11 (package): 70000066701
ndc11 (package): 70000066702
spl id: 199df0a2-bc61-3e83-e063-6394a90ac7dc
spl set id: 199df107-3384-6e03-e063-6294a90afc38

Reported adverse events (FAERS/openFDA)#

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