GO SMILE PM - sodium monofluorophosphate paste, dentifrice 
Go Smile, 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: SODIUM MONOFLUOROPHOSPHATE 0.76% W/W OF FLUORIDE ION.

PURPOSE: ANTICAVITY TOOTHPASTE

USES: AIDS IN THE PREVENTION OF DENTAL CAVITIES.

WARNINGS: KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS FOR USE:

INACTIVE INGREDIENTS: SORBITOL, WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM BENZOATE, SODIUM SACCHARIN, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, VALERIAN OFFICINALIS ROOT EXTRACT.

GO SMILE
LUXURY FLUORIDE TOOTHPASTE
PM
KEEP YOUR SMILE WHITE
GO SMiLE PM 3.5 oz Toothpaste Tube_Front
GO SMiLE PM Toothpaste Drug Facts Box

GO SMILE  PM
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
GLYCERIN 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
TITANIUM DIOXIDE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
CRANBERRY 
VALERIAN 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:44873-002-00100 g in 1 TUBENone
2NDC:44873-002-0128 g in 1 TUBENone
3NDC:44873-002-022 g in 1 PACKETNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/05/2011

Labeler - Go Smile, Inc. (139729631)
Registrant - Go Smile, Inc. (139729631)
Establishment
NameAddressID/FEIOperations
Sheffield Pharmaceuticals001155217manufacture

Revised: 08/2011 Go Smile, Inc.