Label: NOVANA MOISTURIZING- dimethicone 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
    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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