CLOTRIMAZOLE- clotrimazole cream 
Cardinal Health 110 dba LEADER

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Leader Clotrimazole 1% antifungal Athlete's Foot Cream

Active ingredient

Clotrimazole USP 1%

Purpose

Antifungal Cream

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.

Warnings

For External use only.

Keep this and all drugs out of the reach of children

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

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

When using this product

When using this product avoid contact with eyes

Stop use and ask doctor if

Directions

● 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

Inactive Ingredients

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

Questions?

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

5888649 Leader Clotrimazole Cream 1 percent 1oz rev1_24 042924 CDER

5888656 Leader Clotrimazole Cream 1 percent 9.5oz Rev1_24 042924 CDER

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0667
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-23 (UNII: N72LMW566G)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0667-21 in 1 BOX05/10/2024
114 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70000-0667-11 in 1 BOX05/10/2024
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00505/10/2024
Labeler - Cardinal Health 110 dba LEADER (063997360)
Registrant - Trifecta Pharmaceuticals USA (079424163)

Revised: 5/2024
Document Id: 199df0a2-bc61-3e83-e063-6394a90ac7dc
Set id: 199df107-3384-6e03-e063-6294a90afc38
Version: 1
Effective Time: 20240529
 
Cardinal Health 110 dba LEADER