NANO SILVER TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE, GLYCERIN) PASTE [NANOWELL KOREA INC]

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NANO SILVER TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE, GLYCERIN) PASTE [NANOWELL KOREA INC]
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NDC 45163-451-63
Set ID b41b4d44-b048-4171-93c1-2446c655d7f3
Category HUMAN OTC DRUG LABEL
Packager Nanowell Korea Inc
Generic Name
Product Class
Product Number
Application Number PART355
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  • ACTIVE INGREDIENT

    Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin
  • INACTIVE INGREDIENT

    Inactive Ingredients: D-Sorbitol Solution, Polyethylene Glycol 1500, Hydrated Silica, Carboxymethylcellulose Sodium, Chitosan, Sodium Alginate, Tocopherol Acetate, Xylitol, Saccharin Sodium, Methyl Parahydroxybenzoate, Sodium Lauryl Sulfate, Argentum, Mentha Oil, L-Menthol, Purified Water
  • WARNINGS

    Warnings: When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist.  Stop use and ask a dentist if the sensitivity problem persists or worsens.  Sensitive tooth may indicate a serious problem that may need prompt care.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • WHEN USING

    Direction: adults and children 12 yrs and older.  apply at least a half-inch strip of the product onto a soft bristled toothbrush.  Brush teeth thoroughly for at least 3 minutes twice a day (morning and evening).  under 12 yrs ask a dentist.
  • PRINCIPAL DISPLAY PANEL

    BOX LABEL
  • INGREDIENTS AND APPEARANCE
    NANO SILVER TOOTHPASTE 
    sodium monofluorophosphate, silicon dioxide, glycerin paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45163-451
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE1.4 g  in 200 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 200 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 200 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45163-451-63200 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/20/2010
    Labeler - Nanowell Korea Inc (631151268)
    Registrant - Nanowell Korea Inc (631151268)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanowell Korea Inc631151268manufacture
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