Label: ANTI-FUNGAL- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 14, 2013

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  • Active Ingredient

    Clotrimazole 1%

  • Purpose

    Anti-Fungal

  • Use

    For the cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis).  For relief of itching, scaling, burning and discomfort that accompany these conditions.

  • Warnings

    For exteranl use only.

    If swallowed, get medical help or contact a Poison Control Center right away.

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

    Avoid contact with the eyes.

    If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.

    Keep out of reach of children

  • Directions

    Clean the affected area and dry thoroughly. Apply a thin layer of the 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 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 condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

  • Inactive Ingredients

    Alkyl acrylate, Capric triglyceride, Cetearyl alcohol, Diazolidinyl urea, Hydroxyethylcellulose, Methylparaben, Propylparaben, Retinyl palmitate, Silica, Tetrasodium EDTA, Tocopheryl Acetate, Triethanolmine, Water

  • Package Label

    AntiFungalFront

    AntiFungalBack

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66977-023-04113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/14/2002
    Labeler - MPM Medical, Inc. (119643406)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biomed Laboratories, LLC055329696manufacture(66977-023)