Label: DIPHENHYDRAMINE HCL AND ZINC ACETATE- extra strength itch relief continuous spray aerosol, spray

  • NDC Code(s): 56104-015-03
  • Packager: Premier Brands of America Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • Drug Facts Active ingredients

    Diphenhydramine HCl 2%,
    Zinc Acetate 0.1%

  • ​Purpose

    • External analgesic
    • Skin protectant
  • ​Uses

    for the temporary relief of pain and itching associated with:

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

    For external use only.

    Flammable:

    Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

    ​Do not use

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

    ​Stop use and ask doctor if

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

    When using this product

    • avoid contact with eyes
    • use only as directed

    ​Keep out of reach of children.

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

  • ​Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • ​Other information

    store between 20° to 25°C (68° to 77°F)

  • ​ ​Inactive ingredients

    aloe barbadensis leaf juice, glycerin, purified water, sd alcohol 40-B, tromethamine

  • Questions?

    1-888-287-1915

  • ​Principal Display Panel

    Premier

    Extra Strength

    Itch Relief

    Continuous Spray

    Diphenhydramine HCl 2%,

    Zinc Acetate 0.1%

    Spray at any angle

    • External Analgesic
    • Skin Protectant
    • Relieve itching and pain from insect bites, rashes due to poison ivy, sumac and oak

    3FL OZ (88mL)

    PB Itch Relief spray.jpg

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL AND ZINC ACETATE 
    extra strength itch relief continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE1.5 g  in 88 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.075 g  in 88 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-015-0388 mL in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2013
    Labeler - Premier Brands of America Inc. (117557458)
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