Label: FAMILY CARE ANTI-ITCH- diphenhydramine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 16, 2010

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE10 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68169-0049-51 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/16/2010
    Labeler - TAI GUK PHARM. CO., LTD. (631101656)