Label: NOBLE 1 PLUS- xylitol powder, dentifrice

  • NDC Code(s): 60319-4001-1
  • Packager: Hankuk Bowonbio Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 4, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    active ingredient: xylitol<text><contentstyleCode="xmChange"></content></text>

  • INACTIVE INGREDIENT

    cetylpyridinium chloride, lactose monohydrate, corn starch, d-sorbitol, ubidecarenone, glycyrrhizae extract, tea chatechin, hydroxyapatite, propolis extract, menthol powder, spirulina color<text><contentstyleCode="xmChange"></content></text>

  • 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<text><contentstyleCode="xmChange"></content></text>

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children<text><contentstyleCode="xmChange"></content></text>

  • INDICATIONS & USAGE

    apply Proper Amount of the toothpaste on the tooth.<text><contentstyleCode="xmChange"></content></text>

  • WARNINGS

    ■ For tooth only.

    ■ Avoid contact with eyes.

    ■ Do not swallow. If swallowed, get medical help.
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  • DOSAGE & ADMINISTRATION

    brush your teeth by putting appropriate amount of powder
    <text><contentstyleCode="xmChange"></content></text>

  • PRINCIPAL DISPLAY PANEL

    package insert<text><contentstyleCode="xmChange"></content></text>

  • INGREDIENTS AND APPEARANCE
    NOBLE 1 PLUS 
    xylitol powder, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60319-4001
    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
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SORBITOL (UNII: 506T60A25R)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    LICORICE (UNII: 61ZBX54883)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60319-4001-125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2019
    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(60319-4001)