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Go Smile MINT

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE .76g in 100g
Labeler: Go Smile, Inc.
NDC Code: 44873-008

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

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

DIRECTIONS

Adults and children 2 years of age or older – Brush teeth thoroughly for 2 minutes at least twice a day preferably after each meal or as directed by a dentist or doctor.
Children under 6 years of age – Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age – Consult a dentist or doctor

INACTIVE INGREDIENTS

Water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, sodium ascorbyl phosphate, tocopherol, retinyl palmitate, aloe barbadensis leaf juice, flavor, sodium lauryl sulfate, sodium methyl cocoyl taurate, sodium saccharin, cellulose gum, titanium dioxide

USES

Aids in the prevention of dental cavities

ACTIVE INGREDIENTS

‚ÄčSodium Fluoride 0.24% (w/w)

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

GO SMILE  MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-008
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:44873-008-00100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/04/2016
Labeler - Go Smile, Inc. (139729631)
Registrant - Go Smile, Inc. (139729631)

Revised: 10/2016
 
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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