Label: TOOTH WHOLE WHITE- hydrogen peroxide paste, dentifrice

  • NDC Code(s): 60319-5001-1
  • 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

    cetylpyridinium chloride, lactose monohydrate, corn starch, d-sorbitol, ubidecarenone, glycyrrhizae extract, tea chatechin, hydroxyapatite, propolis extract, menthol powder, spirulina color


  • 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 powder


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    TOOTH WHOLE WHITE 
    hydrogen peroxide paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60319-5001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60319-5001-180 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/20/2015
    Labeler - Hankuk Bowonbio Co., Ltd (690045133)
    Registrant - Hankuk Bowonbio Co., Ltd (690045133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankuk Bowonbio Co., Ltd690045133manufacture(60319-5001)
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