Label: CLOTRIMAZOLE cream

  • NDC Code(s): 70000-0667-1, 70000-0667-2
  • Packager: Cardinal Health 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 29, 2024

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  • 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

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

    • 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

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

  • PRINCIPAL DISPLAY PANEL

    5888656 Leader Clotrimazole Cream 1 percent 9.5oz Rev1_24 042924 CDER

  • INGREDIENTS AND APPEARANCE
    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)
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