Label: ITCH REL SPR CVS- diphenhydramine hcl 2% zinc acetate 0.1% 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 December 4, 2017

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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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