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FAMILY CARE ANTI-ITCH (TAI GUK PHARM. CO., LTD.)

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CREAM 1 TUBE in 1 CARTON (68169-0049-5) > 28 g in 1 TUBE Label Information

Complete FAMILY CARE ANTI-ITCH Information

  • ACTIVE INGREDIENT


    Active Ingredients                                                                                  Purpose

    Diphenhydramine Hydrochloride USP, 1%................................................Antihistamine

    Zinc acetate, 0.1%.................................................................................Skin Protectant


  • PURPOSE

    Uses

    • for the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac
    • dries the oozing and weeping of poison ivy, poison oak and poison sumac

  • WARNINGS

    For external use only


  • DO NOT USE

    Do not use

    • on chicken pox, measles, blisters or on extensive areas of the skin
    • any other drug containing diphenhydramine while using this product

  • WHEN USING

    When using this product avoid contact with the eyes


  • STOP USE

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days


  • 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

    Directions

    • adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
    • children under 12 years of age, consult a doctor
    • do not use with any other product containing diphenhydramine, even one taken by mouth
    • discontinue use and consult a physician if rash or irritation develops

  • SAFE HANDLING WARNING

    Other information

    • store at room temperature
    • Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients

    Propylene Glycol, Cetanol, Polyoxyl 40 Stearate, Stearyl Alcohol, Methylparaben, Propylparaben, Purified Water


  • DOSAGE & ADMINISTRATION

    Distributed by:

    Consumer Care Products Corp.

    Cerritos, CA 90703   USA


  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here


  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ANTI-ITCH  
    diphenhydramine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-0049
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 10 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE 1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68169-0049-5 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/16/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)