Go Smile Lemonade

GO SMILE LEMONADE - 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:

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS.
INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION.
CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.

INACTIVE INGREDIENTS: SORBITOL, WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, ESSENTIAL OIL OF LEMON, FLAVOR, CELLULOSE GUM, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, TITANIUM DIOXIDE, SODIUM BENZOATE, SODIUM SACCHARIN, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT.

GO SMILE
LUXURY FLUORIDE TOOTHPASTE
LEMONADE SMILE
KEEP YOUR SMILE WHITE

GO SMiLE Lemonade Smile 3.5 oz Toothpaste Tube_Primary Display

GO SMiLE Lemonade Smile Toothpaste Drug Facts

GO SMILE LEMONADE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44873-003
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	FLUORIDE ION	.76 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
TITANIUM DIOXIDE
SODIUM BENZOATE
SACCHARIN SODIUM
CRANBERRY
LEMON OIL
LEMON JUICE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:44873-003-00	100 g in 1 TUBE	None
2	NDC:44873-003-01	28 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/05/2011

Labeler - Go Smile, Inc. (139729631)

Registrant - Go Smile, Inc. (139729631)

Establishment
Name	Address	ID/FEI	Operations
Sheffield Pharmaceuticals		001155217	manufacture

Revised: 08/2011 Go Smile, Inc.