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)

USES: AIDS IN THE PREVENTION OF DENTAL CAVITIES.

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

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.

ACTIVE INGREDIENTS: SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORIDE ION)

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

GO SMiLE Lemonade Smile 1.0Tube_V2_7_11

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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 (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
LEMON OIL (UNII: I9GRO824LL)  
LEMON JUICE (UNII: AGN709ANTJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44873-003-00100 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:44873-003-0128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/05/201110/27/2015
Labeler - Go Smile, Inc. (139729631)
Registrant - Go Smile, Inc. (139729631)

Revised: 12/2015
Document Id: 1625eeab-a81b-479e-a395-e41b3ca9c6d0
Set id: 72a3d830-faad-4642-ab98-2246b5568078
Version: 11
Effective Time: 20151230
 
Go Smile, Inc.