ZINC OXIDE OINTMENT [CVS]

ZINC OXIDE OINTMENT [CVS]
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NDC 59779-083-02
Set ID 9e398984-576c-4f5f-bb9a-890f56630cf7
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active ingredient                      Purpose
    Zinc oxide 18%.........................Skin protectant
  • PURPOSE

    Uses
    - helps treat and prevent diaper rash
    - protects chafed skin due to diaper rash and
    helps seal out wetness
  • 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
    - helps prevent and treat diaper rash
    - protects chafed skin due to diaper rash and
    helps seal out wetness


  • WARNINGS

    Warnings
    For external use only.
    _______________________________

    When using this product avoid contact with the eyes
    _______________________________

    Stop use and ask a doctor if condition worsens
    or does not improve after seven days

    Keep out of reach of children. If swallowed get
    medical help or contact a Poison Control Center
    right away.
  • DOSAGE & ADMINISTRATION


    Directions
    - change wet and soiled diapers immediately
    - cleanse the diaper area and allow to dry
    - apply ointment liberally and as often as necessary
    with each diaper change and especially when
    exposed to wet diapers for a prolonged period of
    time such as bedtime.
    _______________________________

    Other information

    - Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
    - use with infants children and adults
    - will stain clothing and fabric
  • INACTIVE INGREDIENT

    Inactive Ingredients castor oil, citric acid,
    mineral oil, paraffin, Peruvian balsam, petrolatum

  • PRINCIPAL DISPLAY PANEL

    label


  • INGREDIENTS AND APPEARANCE
    ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-083-02113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/19/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

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