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Name:Nano Silver Toothpaste
Manufacturer:Nanowell Korea Inc
Category:Over-the-counter (OTC) Marketed Drugs


NANO SILVER TOOTHPASTE  - sodium monofluorophosphate, silicon dioxide and 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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:45163-451
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 1.4 g  in 200 g
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 14 g  in 200 g
GLYCERIN (GLYCERIN) GLYCERIN 5 g  in 200 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45163-451-63 200 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/20/2010

Labeler - Nanowell Korea Inc (631151268)
Registrant - Nanowell Korea Inc (631151268)
Establishment
Name Address ID/FEI Operations
Nanowell Korea Inc 631151268 manufacture

Revised: 01/2010 Nanowell Korea Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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