Label: PREMIUM WHITENING- hydrogen peroxide gel, dentifrice

  • NDC Code(s): 60319-1001-1
  • 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 3, 2019

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  • ACTIVE INGREDIENT

    active ingredient: hydrogen peroxide solution
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  • INACTIVE INGREDIENT

    inactive ingredient: polyvinyl alcohol, povidone, sodium stannate, purified water
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  • PURPOSE

    for dental care use
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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
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  • INDICATIONS & USAGE

    apply Proper Amount of the gel on the teeth.

  • WARNINGS

    ■ For tooth only.

    ■ Avoid contact with eyes.

    ■ Do not swallow. If swallowed, get medical help.

  • DOSAGE & ADMINISTRATION

    dry the tooth to be applied

  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    PREMIUM WHITENING 
    hydrogen peroxide gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60319-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE35 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60319-1001-14.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/13/2011
    Labeler - Hankuk Bowonbio Co., Ltd (690045133)
    Registrant - Hankuk Bowonbio Co., Ltd (690045133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankuk Bowonbio Co., Ltd690045133manufacture(60319-1001)
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