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

  • 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 September 13, 2010

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  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Diphenhydramine hydrochloride 2%...................Topical Analgesic
    Zinc acetate....................................................Skin protectant


  • PURPOSE



    Uses

    - for the temporary relief of itching and pain associated with:
    -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, 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

    - for the temporary relief of itching and pain associated with:
    -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, poison oak and poison sumac
  • WARNINGS

    Warnings

    For external use only

    Do not use     on large areas of the body or with any other product containing diphenhydramine,
    even one taken by mouth

    Ask a doctor before use on chicken pox or 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,
    or symptoms persist for ore 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

     adults and children 2 years and older, apply to affected area not more than 3 to 4 times daily, or as directed by a doctor

    children under 2 years of age: consult a doctor

    Other information

    - store at 20 degrees - 25 degrees C (68 to 70 degrees F) - Lot No. and Exp. Date, see crimp of tube or see box
     
  • INACTIVE INGREDIENT

    Inactive Ingredients

    cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate,
    propylene glycol, propylparaben, purified water
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS EXTRA STRENGTH ITCH RELIEF 
    diphenhydramine hydrochloride and zinc acetate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS) ZINC ACETATE12 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-053-031 in 1 CARTON
    128 g in 1 TUBE
    2NDC:59779-053-111 in 1 CARTON
    214 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/13/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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