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.

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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.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	1.4 g in 200 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	14 g in 200 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5 g in 200 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45163-451-63	200 g in 1 TUBE

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

Labeler - Nanowell Korea Inc (631151268)

Registrant - Nanowell Korea Inc (631151268)

Name	Address	ID/FEI	Business Operations
Establishment
Nanowell Korea Inc		631151268	manufacture