Label: ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

  • NDC Code(s): 72476-295-20
  • Packager: Retail Business Services, LLC
  • 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 September 20, 2023

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  • 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:
    ■ insect bites ■ minor skin irritations ■ sunburn
    ■ minor burns ■ minor cuts ■ scrapes
    ■ rashes due to poison: ■ ivy ■ oak ■ sumac
    ■ dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

  • Warnings

    For external use only

    Flammable. Keep away from fire of 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 or measles

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    condition worsens or symptoms last 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

    • store at 20⁰ to 25⁰C (68⁰ to 77⁰F)

  • Inactive ingredients

    alcohol, glycerin, povidone, purified water, tris (hydroxymethyl) aminomethane

  • SPL UNCLASSIFIED SECTION

    Not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Benadryl Spray*

    DIST. BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949 Ahold Delhaize Licensing Sari

    Quilty guaranteed or money back

  • principal display panel

    TEAR HERE

    CAREONE

    Itch Relief Spray

    TOPICAL ANALGESIC

    SKIN PROTECTANT

    Pain and Itch Reliever

    COMPARE TO THE ACTIVE INGREDIENTS IN BENADRYL SPRAY*

    RELIEVES ITCHING DUE TO INSECT BITES, POISON OAK OR IVY, OR OTHER MINOR SKIN IRRITATIONS

    OUR PHARMACISTS RECOMMEND

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hcl, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 kg  in 100 L
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-295-200.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/06/2011
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72476-295)
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