Label: NOVANA ALL-IN-ONE ONE STEP PERINEAL- dimethicone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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


  • PURPOSE

    Uses Temporarily protects and helps relieve chapped or cracked skin.

  • WARNINGS

    Warnings
    For external use only.
    When using this product • Avoid contact with eyes • Stop use and ask doctor if  • 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.

    For external use only.

  • INDICATIONS & USAGE

    Directions •Apply as needed. • Change wet and soiled undergarments. • Apply to affected area and gently wipe with clean, soft cloth. • Use with each undergarment change, especially at bedtime or any time when exposure to wet garments may be prolonged.
  • INACTIVE INGREDIENT

    Inactive ingredients
    Water, Cetyl Alcohol, Stearyl Alcohol, Glycine Soja (Soybean) Oil, Propanediol, Polysorbate 60,
    Panthenol, Glycerin, Isopropyl Myristate, Allantoin, Tocopherol, Sodium Laureth Sulfate, Citric Acid,
    Phenoxyethanol, Iodopropynyl Butylcarbamate

  • PRINCIPAL DISPLAY PANEL

    Label of Product
  • INGREDIENTS AND APPEARANCE
    NOVANA ALL-IN-ONE ONE STEP PERINEAL 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-500
    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)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Soybean Oil (UNII: 241ATL177A)  
    Propanediol (UNII: 5965N8W85T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Panthenol (UNII: WV9CM0O67Z)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Allantoin (UNII: 344S277G0Z)  
    Tocopherol (UNII: R0ZB2556P8)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76077-500-08240 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/04/2012
    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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