Label: ITCH RELIEF- diphenhydramine hcl, zinc acetate spray

  • NDC Code(s): 41250-295-20
  • Packager: Meijer Distribution, 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 November 1, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients

    Diphenhydramine HCL 2%

    Zinc acetate 0.1%

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  • Purpose

    External analgesic

    Skin protectant

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  • Uses

    • for the temporary relief of pain and itching associated with minor skin irritations
    • dries the oozing and weeping of poison: ivy, oak, sumac
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  • Warnings

    For external use only

    Flammable.  Keep away from fire or flame.

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  • Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
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  • Ask a doctor before use

    on chicken pox or measles

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  • When using this product

    do not get in eyes

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  • 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

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  • Keep out of reach of children.

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

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  • 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
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  • Other information

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

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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Benadryl Spray.

    Distributed by Meijer Distribution, Inc.

    Grand Rapids, MI 49544

    www.meijer.com

    295.000/295AB

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  • Principal display panel

    Meijer

    *Compare to the active ingredients in Benadryl Spray

    Itch Relief Spray

    topical analgesic

    skin protectant

    Pain & Itch Reliever

    2 FL OZ (59 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hcl, zinc acetate spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-295
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 18 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 882 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-295-20 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/01/2018
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(41250-295)
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