Drug Labeling and Warnings

Drug Details

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GO SMILE REFRESH- 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.

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, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

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

GO SMiLE AM 1.0 ozTube_V4_7_11

GO SMiLE AM 3.5 ozTube_V4_7_11

GO SMILE  REFRESH
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 44873-006
Route of AdministrationORAL
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 (UNII: 05JZI7B19X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 44873-006-00100 g in 1 TUBE; Type 0: Not a Combination Product10/27/2015
2NDC: 44873-006-0128 g in 1 TUBE; Type 0: Not a Combination Product10/27/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/27/2015
Labeler - Go Smile, Inc. (139729631)
Registrant - Go Smile, Inc. (139729631)

Revised: 11/2019
 
Go Smile, Inc.


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