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% (0.13% W/V FLUORIDE ION)

PURPOSE: ANTICAVITY

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:
  • 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, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, CITRUS MEDICA LIMONUM (LEMON) FLOWER/LEAF/STEM OIL, CELLULOSE GUM, CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT, TITANIUM DIOXIDE, SODIUM BENZOATE, SODIUM SACCHARIN.

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GO SMILE  LEMONADE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-003
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 
LEMON OIL 
LEMON JUICE 
Packaging
#Item CodePackage Description
1NDC:44873-003-00100 g in 1 TUBE
2NDC:44873-003-0128 g in 1 TUBE
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)

Revised: 04/2012
 
Go Smile, Inc.