Label: NBF GINGIVAL- sodium monofluorophosphate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 11, 2011

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  • ACTIVE INGREDIENT

    active ingredient: sodium monofluorophosphate
  • INACTIVE INGREDIENT

    inactive ingredient: silicon dioxide, triclosan, glycerin, d-sorbitol, polyethylene glycol, chitosan oligosaccharide, carboxymethylcellulose sodium, propolis extract, xylitol, sacccharin sodium hydroate, peppermint oil, l-menthol, sodium benzoate, ascorbic acid, tocopherol, purified water
  • PURPOSE

    ■ prevention of gingival disease
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    apply toothpast on soft bristle toothbrush and brush
  • WARNINGS

    if irritation occurs when using this product, discontinue use
  • DOSAGE & ADMINISTRATION

    ■ apply three times a day after meals
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    NBF GINGIVAL 
    sodium monofluorophosphate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23636-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.4 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23636-1001-130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/11/2011
    Labeler - NanoCureTech (557799555)
    Registrant - NanoCureTech (557799555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd689787898manufacture
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