Label: DISCOUNT DRUG MART EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Active Ingredients

    Diphenhydramine hydrochloride 2%

    Zinc acetate 0.1%

  • Purpose

    Diphenhydramine hydrochloride...............Topical anagesic

    Zinc acetate..............................................Skin protectant

  • Uses

    temporarliy relieves pain and itching due to:

    • 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 due to poison:

    • ivy
    • oak
    • sumac
  • Warnings

    For external use only

    Do not use

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

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • do not use more often than directed
    • adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years: ask a doctor
  • Other Information

    • store at 20º C to 25º C (68º F to 77º F)
  • Inactive Ingredients

    cetyl alcohol, diazolidinyl urea, glyceryl stearate, methylparaben, PEG-40 stearate, PEG-100 stearate, propylene glycol, propylparaben, purified water

  • Package Label - 1oz (28g)

    Extra Strength ITCH STOPPING CREAM

    Topical Analgesic / Skin Protectant

    Net wt. 1 oz (28 g) Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    DISCOUNT DRUG MART EXTRA STRENGTH ITCH STOPPING 
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-258
    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
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-258-011 in 1 CARTON03/17/2014
    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 DrugM01703/17/2014
    Labeler - Discount Drug Mart (047741335)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(53943-258)
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