NANO SILVER TOOTHPASTE - sodium monofluorophosphate, silicon dioxide, glycerin paste 
Nanowell Korea Inc

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.

----------

Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin

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: 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.  If accidentally swallowed, get medical help or contact a Poison Control Center right away.

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.

BOX LABEL
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

Revised: 1/2010
Document Id: 41da3fff-f7b1-42d3-94c0-a21687449983
Set id: b41b4d44-b048-4171-93c1-2446c655d7f3
Version: 2
Effective Time: 20100118
 
Nanowell Korea Inc