Label: GNP EXTRA STRENGTH ANTI-ITCH CREAM- diphenhydramine hydrochloride, zinc acetate cream

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

Drug Label Information

Updated May 8, 2025

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  • Active Ingredients

    Diphenhydramine hydrochloride 2%

    Zinc acetate 0.1%

  • Ask Doctor Section

    conditions worsen

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

  • Do not use section

    on chicken pox, poison ivy, sunburn, large areas of the body, broken, blistered, or oozing skin, more often than directed, or with any other product containing diphenhydramine, even one taken by mouth

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    For external use only

  • Directions

    do not use more often then 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 doctor

  • Uses

    temporarily relieves pain and itching due to:

    • insect bites
    • minor burns
    • sunburns
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak and poison sumac
    • dries the oozing and weeping of poison:
      • Ivy
      • oak
      • sumac
  • OTHER SAFETY INFORMATION

    Store at 20C to 25C (68F to 77F)

  • QUESTIONS

    www.mygnp.com

  • INACTIVE INGREDIENT

    ceytl alcohol

    diazolindinyl urea

    methlparaben

    polyethylene glycol

    monostearate 1000

    propylene glycol

    propylparaben

    purified water

    stearyl alcohol

  • PURPOSE

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

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

  • PRINCIPAL DISPLAY PANEL

    68-258-51v3.0

  • INGREDIENTS AND APPEARANCE
    GNP EXTRA STRENGTH ANTI-ITCH CREAM 
    diphenhydramine hydrochloride, zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 g
    DIPHENHYDRAMINE HCL (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HCL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-804-361 in 1 CARTON06/01/2025
    11 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2025
    Labeler - Amerisource Bergen (007914906)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc005290028manufacture(46122-804)
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