Label: CVS EXTRA STRENGTH ITCH RELIEF- diphenhydramine hydrochloride and zinc acetate spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 27, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                                                               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 ivy, poison oak and poison
    sumac. Dries the oozing and weeping of poison ivy, poison oak and poison sumac.


  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact a
    Poison Control Center right away.

  • INDICATIONS & USAGE


    Uses

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

  • WARNINGS

    Warnings

    For external use only. Flammable. keep away from fire or flame.

    Do not use     -  with any other product containing diphenhydramine,
    even one taken 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 the eyes

    Stop use and ask a doctor if condition worsens or does not improve within 7 days.
    - symptoms persist for 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.
  • DOSAGE & ADMINISTRATION


    Directions

    - do not use more 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 of age:     consult a doctor

    Other information

    Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    purified water, SD alcohol 40-B, glycerin, povidone, tromethamine
  • PRINCIPAL DISPLAY PANEL


    c



  • INGREDIENTS AND APPEARANCE
    CVS  EXTRA STRENGTH ITCH RELIEF
    diphenhydramine hydrochloride and zinc acetate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-248
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 mL
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE (UNII: FZ989GH94E)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-248-2559 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/10/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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