Label: BENADRYL EXTRA STRENGTH ITCH STOPPING- diphenhydramine hydrochloride and zinc acetate cream

  • NDC Code(s): 69968-0223-1, 69968-0223-2
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Diphenhydramine hydrochloride 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.

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

    • protect from excessive heat (40˚C/104˚F)
  • Inactive ingredients

    cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

  • Questions or comments?

    ca ll 1-877-717-2824 tol l-free or 215-273-8755 (co llect) www.benadryl.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Kenvue Brands LLC.
    Summit, NJ 07901

  • PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

    Benadryl® ®

    THE HISTAMINE

    BLOCKER TM

    Relief from most outdoor itches

    EXTRA STRENGTH

    For Ages 2+

    ITCH STOPPING

    CREAM

    Diphenhydramine HCl 2%

    / Topical Analgesic

    Zinc acetate 0.1% / Skin

    Protectant

    Insect Bites

    Poison Ivy,

    Oak, Sumac

    Mosquito

    Bites

    Sunburn

    Minor Cuts

    & Scrapes

    NET WT.1 OZ (28.3g)

    Benadryl

  • INGREDIENTS AND APPEARANCE
    BENADRYL EXTRA STRENGTH  ITCH STOPPING
    diphenhydramine hydrochloride and zinc acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0223-11 in 1 CARTON11/01/2009
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69968-0223-228.3 g in 1 TUBE; Type 0: Not a Combination Product11/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2009
    Labeler - Kenvue Brands LLC (118772437)
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