Label: K-MOM KIDS TOOTH- silica, sodium monofluorophosphate paste, dentifrice

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

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Drug Label Information

Updated November 26, 2019

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  • ACTIVE INGREDIENT

    Silica, Sodium Monofluorosphate

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Brush your teeth with a suitable amount of brush

  • WARNINGS

    Keep out of the reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

    Sorbitol, Water, Glycerin, Stevioside, Hydrated Silica, etc.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    K-MOM KIDS TOOTH 
    silica, sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73429-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE2 g  in 100 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.35 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73429-0001-150 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2019
    Labeler - MOTHER-K CO.,LTD (689540220)
    Registrant - MOTHER-K CO.,LTD (689540220)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPHARMACEUTICAL Co.,Ltd.688679158manufacture(73429-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    MOTHER-K CO.,LTD689540220label(73429-0001)
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