Label: NOVANA PROTECT BARRIER- zinc oxide cream

  • 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 4, 2012

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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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