ITCH REL SPR CVS (DIPHENHYDRAMINE HCL 2% ZINC ACETATE 0.1%) SPRAY [CVS]

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ITCH REL SPR CVS (DIPHENHYDRAMINE HCL 2% ZINC ACETATE 0.1%) SPRAY [CVS]
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NDC 69842-845-02
Set ID 79a18783-6885-469f-bb16-b1d5e2812001
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredients                          Purpose

    Diphenhydramine HCl – 2%           Topical analgesic
    Zinc Acetate – 0.1%                        Skin Protectant

  • PURPOSE

  • Uses

    temporarily relieves itching and pain associated with minor irritations, burns, scrapes, cuts, insect bites and rashes due to poison oak & poison sumac. Dries the oozing and weeping of poison ivy, poison oak & poison sumac.

  • Warnings For external use only. Flammable. Keep away from fire or flame.

    ​Do not use • with any other product containing Diphenhydramine, even onetaken by mouth • on large areas of the body

    Ask a doctor before use

    • on chicken pox

    • on measles

    ​When using this product​ • avoid contact with eyes

    Stop use and ask a doctor if
    • condition worsens or does not improve within 7 days
    • symptoms persist more than 7 days or clear up and occur again within a few days

    Keep out of reach of the children
    If product is 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 20 ​o​ - 25 ​o​C (68 ​o​ - 77 ​o​F)

  • Inactive ingredients

    Alcohol, Glycerin, Povidone, Purified Water, Tromethamine

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ITCH REL SPR   CVS
    diphenhydramine hcl 2% zinc acetate 0.1% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-845
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
    ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 g  in 100 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:69842-845-0259 mL in 1 CAN; Type 0: Not a Combination Product02/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/14/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-845) , label(69842-845)
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