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Go Smile RELAX

Medically reviewed on October 21, 2016

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE .76g in 100g
Labeler: Go Smile, Inc.
NDC Code: 44873-007

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.

PURPOSE

ANTICAVITY

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, VALERIAN OFFICINALIS RHIZOME/ROOT EXTRACT.

PURPOSE

ANTICAVITY

ACTIVE INGREDIENTS

‚ÄčSODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% W/V FLUORINE ION)

WARNINGS

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

GO SMILE  RELAX
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-007
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 
VALERIAN 
Packaging
#Item CodePackage Description
1NDC:44873-007-00100 g in 1 TUBE
2NDC:44873-007-0128 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)

 
Go Smile, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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