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

  • NDC Code(s): 69968-0270-2
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 May 8, 2023

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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 not finalpart34804/01/2019
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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