QUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE EXTRA STRENGTH ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-947-30
Set ID 6b99d52d-6e5f-4b5f-beae-bb1107007163
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class
Product Number
Application Number PART336
  • ACTIVE INGREDIENT

    Active Ingredients                                                                               Purpose

    Diphenhydramine hydrochloride USP, 2%.............................................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, and poison sumac
    • dries 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 chicken pox, measles, sunburn, oozing skin, broken blisters or on extensive areas of the skin more than directed
    • 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 persists 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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    glycerin, sodium chloride, petrolatum, cetyl alcohol, dimethicone, isopropyl palmitate, distearyldimodium chloride (1-Octadecanaminium, N, N-Dimmethyl-N-Octadecyl-Chloride), methylparaben, propylparaben, purified water, hydroxyethyl cellulose

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY QUALITY CHOICE

    NOVI, MI 48376-0995

    MADE IN KOREA

    QC 94731

    www.chaindrug.com

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE EXTRA STRENGTH ANTI ITCH 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-947
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-947-301 in 1 CARTON
    130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/13/2012
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

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