Label: CLOTRIMAZOLE CREAM, 1%- clotrimazole cream

  • NDC Code(s): 45861-099-07
  • Packager: Pharmaceutica North America, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active Ingredient

    Clotrimazole USP 1%

  • Purpose

    Antifungal

  • Uses

    Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

    Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

  • Warnings

    • For external use only
    • Do not useon children under 2 years of age unless directed by a doctor. 
    • When using this product, avoid contact with eyes. 
    • Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (for athletes foot or ringworm) or within 2 weeks (for jock itch)
    • Keep this and all drugs out of reach of children. In case of a accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Wash the affected area and dry thoroughly
    • Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.
    • Supervise children in the use of this product.
    • For athletes' 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 athletes foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
    • If condition 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 (50 – 86F)
    • Close cap tightly after use.

  • Inactive Ingredients

    Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE CREAM, 1% 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45861-099
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERETH-31 (UNII: 11L9WC241B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45861-099-0729 g in 1 TUBE; Type 0: Not a Combination Product12/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00512/10/2024
    Labeler - Pharmaceutica North America, Inc (962739699)