Label: APTRIMAZOLE 1.0% ANTIFUNGAL CREAM- 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 April 27, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    CLOTRIMAZOLE

  • PURPOSE

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Cures most athlete's foot, jock itch, and ringworm.

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



  • Do not use:

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

    Avoid contact with eyes.

    For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.







  • Direction:

    Clean the affected area and dry thoroughly. Apply a layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

    Foe athlete's foot and ringworm, use daily for 4 weeks.

    For jock itch, use daily for 2 weeks.

    If conditions persist longer, consult a doctor.

    This product is not effective on scalp or nails.



  • INACTIVE INGREDIENT


    PETROLATUM

    LIGHT MINERAL OIL

    CETOSTEARYL ALCOHOL

    EDETIC ACID

    CHLOROCRESOL

    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

    POLYSORBATE 60

    CETETH-20

  • DISPLAY PANEL

    product
  • INGREDIENTS AND APPEARANCE
    APTRIMAZOLE  1.0% ANTIFUNGAL CREAM
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-081
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETETH-20 (UNII: I835H2IHHX)  
    Product Characteristics
    Colorwhite (offwhite) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-081-3115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/27/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-081)