Label: ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

  • 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 October 3, 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 minor skin irritations
    • dries the oozing and weeping of poison: ivy, oak, 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 or measles

  • When using this product

    do not get in eyes

  • Stop use and ask a doctor if

    condition worses 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 25⁰ C (68⁰ to 77⁰ F)

  • 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

    DISTRIBUTED BY ONE EAST MAIN CO.

    100 MISSION RIDE

    GOODLETTSVILLE, TN 37072

  • principal display panel

    TEAR HERE

    DG health

    Compare to active ingredents in Benadryl Spray

    Itch Relief Spray

    External Analgesic

    Skin Protectant

    Relieves itching due to insect bites, poison oak or ivy, or other monor skin irritations

    100% Satisfaction Guaranteed! (888)309-9030

    2 FL OZ (59 mL)

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  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hcl, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-295
    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 (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-295-2059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/14/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/14/2010
    Labeler - OLD EAST MAIN CO (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-295)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-295)
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