ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [AMERICAN SALES COMPANY]

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ITCH RELIEF (DIPHENHYDRAMINE HCL, ZINC ACETATE) SPRAY [AMERICAN SALES COMPANY]
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NDC 41520-295-16
Set ID 3fad67da-58ce-4f5f-b8c1-738d44656ce6
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
Generic Name
Product Class
Product Number
Application Number PART348
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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: iv, 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 - 25⁰C (68⁰ - 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*

    Distributed by: American Sales Company
    4201 Walden Avenue, Lancaster, NY 14086
    S+S BRANDS. INC www.Care1.info
    Quality guaranteed or your money back

  • principal display panel

    TEAR HERE
    Compare to Active Ingredients in Benadryl Spray*
    CAREONE ITCH RELIEF SPRAY
    SKIN PROTECTANT
    TOPICAL ANALGESIC
    Relieves itching due to insect bites poison oak or ivy, or other minor skin irritations
    2 FL OZ (59 mL)

    295.000/295AB

    image description

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    diphenhydramine hcl, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-295
    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:41520-295-160.059 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 - American Sales Company (809183973)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(41520-295)
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