Label: NANO SILVER TOOTHPASTE- sodium monofluorophosphate, silicon dioxide, glycerin paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 18, 2010

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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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