Label: DG HEALTH ANTI ITCH- diphenhydramine hydrochloride, zinc acetate 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 September 14, 2016

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  • ACTIVE INGREDIENT

    Active ingredients                                                                       Purpose

    Diphenhydramine Hydrochloride 2% ............................................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 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 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 the 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 right away

  • INDICATIONS & USAGE

    Directions

    • do not use more than directed
    • adults and children 2 years of age and older: apply to affected area no more than 3-4 times daily
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 20o to 25oC (68o-77oF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    propylene glycol, cetyl alcohol, polyoxyl 40 stearate, methylparaben, propylparaben, purified water.

  • DOSAGE & ADMINISTRATION

    Distributed By

    Dolgencorp, LLC

    100 Mission Ridge

    Goodlettsville, TN 37072

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DG HEALTH ANTI ITCH 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    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:55910-305-281 in 1 CARTON09/14/2016
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/17/2011
    Labeler - DOLGENCORP, INC. (068331990)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiguk Pharm. Co., Ltd._Buyeo branch689060246manufacture(55910-305)
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