NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]

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NOVANA PROTECT BARRIER (ZINC OXIDE) CREAM [NOVANA MEDICAL LLC]
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NDC 76077-300-04, 76077-300-07
Set ID c857326a-655c-428d-ab96-a2da492194e6
Category HUMAN OTC DRUG LABEL
Packager NOVANA MEDICAL LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active ingredient                             Purpose
    Zinc Oxide 12%...............................Skin Protectant

  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only.

    When using this product • Do not get in eyes. Stop use and ask doctor if •condition worsens • symptoms last more than 7 days or clear up and occur again within a few days. Do not use on • deep or puncture wounds • animal bites • serious burns

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

  • INSTRUCTIONS FOR USE

    Directions  • Apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredients
    Cetyl Alcohol,Cod Liver Oil, Diazolidinyl Urea, Dimethicone, Glyceryl Stearate, Lanolin Oil, Methylparaben, Petrolatum, Propanediol, Propylene Glycol, Propylparaben, Sodium Laureth Sulfate, Water

  • PRINCIPAL DISPLAY PANEL


    Label of Package

  • INGREDIENTS AND APPEARANCE
    NOVANA PROTECT BARRIER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide.12 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Lanolin (UNII: 7EV65EAW6H)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cod Liver Oil (UNII: BBL281NWFG)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76077-300-04120 mL in 1 TUBE
    2NDC:76077-300-07210 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/04/2012
    Labeler - NOVANA MEDICAL LLC (964916600)
    Registrant - O.L. PRODUCTS, INC. (961405883)
    Establishment
    NameAddressID/FEIBusiness Operations
    O.L. PRODUCTS, INC. 961405883label, manufacture
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