Label: DISCOUNT DRUG MART REGULAR STRENGTH ITCH STOPPING- 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 April 24, 2019

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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

    Discount Drug Mart

    Relieves pain from insects bites & skin irritation

    Topical Analgesic

    Skin Protectant

    REGULAR STRENGTH ITCH STOPPING CREAM

    compare to the active ingredients in Benadryl ® Orignial strength itch stopping cream

    Relieves Pain & Itch fast

    Itch stopping Cream

    discount drug mart regular strength itch stopping cream .jpg

  • INGREDIENTS AND APPEARANCE
    DISCOUNT DRUG MART REGULAR STRENGTH ITCH STOPPING 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE10 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-261-011 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 not finalpart34803/17/2014
    Labeler - Discount Drug Mart (047741335)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028manufacture(53943-261)
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