Label: CVS ITCH RELIEF- diphenhydramine hcl, zinc acetate 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 April 22, 2019

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  • Active Ingredient

    Diphenhydramine hydrochloride 2% Topical analgesic

    Zinc acetate 0.1% Skin protectant

  • Uses

    for

    temporary relieves pain and itching due to:

    insect bites

    minor burns

    sunburn

    minor skin irritations

    minor cuts

    scrapes

    rashes due to poison ivy, poison oak, and poison sumac

    dries the oozing and weeping of poison:

    ivy

    oak

    sumac

  • Directions

    do not use more often than directed

    adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

  • Warnings

    For external use only

    Do not Use

    on large areas of the body

    with any other product containing diphenhydramine, even one taken by mouth

    Ask doctor Before use

    on chicken pox

    on measles

    When using this product

    do not get into eyes

    Stop Use and ask physician

    condition worsens

    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.

    Warning

    for external use only

  • Purposes

    Itch relief

  • Inactive Ingredients

    Purified Water, Glycerin, SD Alcohol, Povidone, Povidonee (K-30), Trolamine

  • Prinicpal dispaly panel

    CVS itch spray .jpg

    Diphenhydramine hydrochloride 2%

    Topical analgesic

    Zinc acetate 0.1% Skin protectant

    Relieves Itch and Pain associated with insects bites & rashes due to posinon ivy Oak& sumac

  • INGREDIENTS AND APPEARANCE
    CVS ITCH RELIEF 
    diphenhydramine hcl, zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-952
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.1 g  in 100 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-952-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/14/2014
    Labeler - CVS (062312574)
    Registrant - Weeks & LEO, Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo005290028manufacture(69842-952)
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