EFFECTIVE ITCH RELIEF (DIPHENHYDRAMINE HCI, ZINC ACETATE) SPRAY [TOPCO]

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EFFECTIVE ITCH RELIEF (DIPHENHYDRAMINE HCI, ZINC ACETATE) SPRAY [TOPCO]
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NDC 36800-739-03
Set ID 66759e41-bcfb-4eff-9409-928acf361ba6
Category HUMAN OTC DRUG LABEL
Packager TopCo
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredients

    Diphenhydramine HCl 2.0%

    Zinc Acetate 0.10%

  • Purpose

    Topical analgesic

    Skin protectant

  • Uses

    Temporarily relieves pain and itching associated with:

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

    For external use only.

    Flammable - Do not use while smoking or near heat or flame ​​​​

  • Do not use

    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
    • on chicken pox
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and occur again in a few days
  • WHEN USING

    When using this product

    keep out of eyes
    use only as directed.
    do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F

  • Keep out of reach of children.

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

  • Directions

    • shake well
    • 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
    • to apply to face, spray into palm of hand and gently apply
  • Inactive ingredients

    Alcohol Denat.
    Glycerin
    PVP
    Tromethamine
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EFFECTIVE ITCH RELIEF 
    diphenhydramine hci, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-739
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2.0 g  in 100 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION.10 g  in 100 g
    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:36800-739-0385 g in 1 CAN; Type 0: Not a Combination Product01/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/22/2013
    Labeler - TopCo (006935977)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(36800-739) , label(36800-739)
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