NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]

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NOVANA MOISTURIZING (DIMETHICONE) CREAM [NOVANA MEDICAL LLC]
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NDC 76077-200-04, 76077-200-07, 76077-200-09
Set ID b93a9119-e910-4c5e-ba4d-cbdd11b1f32d
Category HUMAN OTC DRUG LABEL
Packager NOVANA MEDICAL LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT


    Active ingredient                 Purpose
    Dimethicone 2%...................Skin Protectant


    Uses Helps to prevent and temporarily protect chafed, chapped, or cracked skin.

    Warnings
    When using this product • Do not get into 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.

    For external use only.

    Inactive ingredients
    Water, Lanolin Oil, Cod Liver Oil, Propylene Glycol, Polyethylene, Sodium Polyacrylate, Cetyl Alcohol, Beeswax, Glyceryl Stearate, Caprylic/Capric Triglyceride, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Sodium Laureth Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

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

    Directions
    Apply as needed.

  • PRINCIPAL DISPLAY PANEL

    label image
  • INGREDIENTS AND APPEARANCE
    NOVANA MOISTURIZING 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone.02 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Lanolin (UNII: 7EV65EAW6H)  
    Cod Liver Oil (UNII: BBL281NWFG)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76077-200-04120 mL in 1 TUBE
    2NDC:76077-200-07210 mL in 1 TUBE
    3NDC:76077-200-09270 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/04/2012
    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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