Label: BENADRYL EXTRA STRENGTH ITCH COOLING- diphenhydramine hydrochloride and zinc acetate spray

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

Drug Label Information

Updated November 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Diphenhydramine HCl 2%Topical analgesic
    Zinc acetate 0.1%Skin protectant
  • 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

    For external use only.

    Flammable. Keep away from fire or flame.

    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 avoid contact with eyes

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

  • Directions

    • do not use more than directed
    • adults and children 2 years of age and older: spray on affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • Other information

    • store at 20° to 25° C (68° to 77° F)
  • Inactive ingredients

    alcohol, glycerin, PVP, purified water, tromethamine

  • Questions?

    call 1-800-524-2624 (English/Spanish)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    Benadryl®

    Relief for most outdoor itches

    EXTRA STRENGTH

    ITCH COOLING SPRAY

    Diphenhydramine HCl 2% / Topical Analgesic

    Zinc acetate 0.1 % / Skin Protectant

    Questions?

    call 1-877-717-2824 (toll-free)

    or 215-273-8755 (collect)

    www.benadryl.com

    Insect

    Bites     		Poison Ivy,

    Oak, Sumac     		Mosquito

    Bites     		SunburnMinor Cuts

    & Scrapes

    Distributed by:

    JOHNSON & JOHNSON

    CONSUMER INC.

    Skillman, NJ 08558

    J&JCI 2023 Made in Canada

    Pat.www.jjcipats.com

    2 FL OZ (59 mL)

    Benadryl_01

  • INGREDIENTS AND APPEARANCE
    BENADRYL EXTRA STRENGTH ITCH COOLING 
    diphenhydramine hydrochloride and zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0270-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2019
    Labeler - Kenvue Brands LLC (118772437)
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