FAMILY CARE ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE) CREAM [UNITED EXCHANGE CORP.]

FAMILY CARE ANTI-ITCH (DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE) CREAM [UNITED EXCHANGE CORP.]
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NDC 65923-495-28
Set ID 1fff5104-05ae-4ab2-882a-282b5de38bfe
Category HUMAN OTC DRUG LABEL
Packager United Exchange Corp.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active Ingredients                                                                            Purpose

    Diphenhydramine hydrochloride 1%................................................ Topical analgesic

    Zinc acetate 0.1%........................................................................ Skin protectant

  • PURPOSE

    Uses

    Temporarily relieves pain and itching associated with:

    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy
    • poison oak
    • poison sumac
    • drise the oozing and weeping of poison ivy, poison oak, and poison sumac
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
  • ASK DOCTOR

    Ask a doctor before use

    • on chicken pox
    • on measles
  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • 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 immediately

  • INDICATIONS & USAGE

    Directions

    • do not use more than directed
    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos CA 90703 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ANTI-ITCH 
    diphenhydramine hydrochloride zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-495
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE1 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-495-281 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/24/2014
    Labeler - United Exchange Corp. (840130579)

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