Label: NOBLE G PLUS- xylitol paste, dentifrice

  • NDC Code(s): 60319-3001-1
  • Packager: Hankuk Bowonbio Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 5, 2019

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  • ACTIVE INGREDIENT

    active ingredient: xylitol

  • INACTIVE INGREDIENT

    silicone dioxide, sodium monofluorophosphate, hydrated silicone dioxide, d-sorbitol, carboxymethylcellulose sodium, sodium lauryl sulfate, sodium saccharin, gold leaf, green tea extract, polyethylene glycol 1500, L-menthol, hydroxyapatite, chitosan, stearic acid, polysorbate 80, water

  • PURPOSE

    whiten and strong teeth
    removal of bad breath
    prevention of gingivitis and periodontitis
    prevention of periodontal diseases and gum diseases
    removal of dental plaque

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply Proper Amount of the toothpaste on the tooth.

  • WARNINGS

    ■ For tooth only.
    ■ Avoid contact with eyes.
    ■ Do not swallow. If swallowed, get medical help.

  • DOSAGE & ADMINISTRATION

    brush your teeth by putting appropriate amount of tooth paste

  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    NOBLE G PLUS 
    xylitol paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60319-3001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL0.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    GOLD (UNII: 79Y1949PYO)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60319-3001-1130 g in 1 TUBE; Type 0: Not a Combination Product12/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/30/2012
    Labeler - Hankuk Bowonbio Co., Ltd (690045133)
    Registrant - Hankuk Bowonbio Co., Ltd (690045133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankuk Bowonbio Co., Ltd690045133manufacture(60319-3001)
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