Label: QUALITY CHOICE EXTRA STRENGTH ANTI ITCH- diphenhydramine hydrochloride, zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 13, 2012

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  • 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)