Label: CLOTRIMAZOLE cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 8, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DOSAGE AND ADMISITRATION

    Clotrimazole 1% ..

    Clean the affected area and dry thoroughly. Apply a thin 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 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

  • Warnings

    For External Use Only
    Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
    When using this product Avoid contact with the eyes
    Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
    improvement within 4 weeks when used for athlete’s foot or ringworm

  • INACTIVE INGREDIENT

    Cetostearyl Alcohol, Methylparaben, Mineral Oil, Macrogol cetostearyl ether, Propylene Glycol, Propylparaben, Purified Water, White Petrolatum

  • INDICATIONS & USAGE

    For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch and itching or burning feet

  • 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.

  • PURPOSE

    Antifungal

  • WARNINGS

    For External Use Only
    Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
    When using this product Avoid contact with the eyes
    Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
    improvement within 4 weeks when used for athlete’s foot or ringworm

  • PRINCIPAL DISPLAY PANEL

    clotrimazole

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84387-004
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84387-004-0128.4 g in 1 TUBE; Type 0: Not a Combination Product11/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00511/08/2024
    Labeler - ALLIED TRADE LINK LLC (029033682)
    Registrant - ALLIED TRADE LINK LLC (029033682)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOLPALDAS VISRAM AND COMPANY LIMITED858030888manufacture(84387-004)