GO SMILE MINT- sodium fluoride paste, dentifrice 
Go Smile, Inc.

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GOSMILE (as PLD) - TOOTHPASTE, MINT (44873-008)

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

Sodium 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.

Toothpaste_Box_Final_OL_Crop Dieline

GO SMILE  MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44873-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 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)  
VALERIAN (UNII: JWF5YAW3QW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44873-008-00100 g in 1 TUBE; Type 0: Not a Combination Product05/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02105/04/2016
Labeler - Go Smile, Inc. (139729631)

Revised: 11/2023
Document Id: 0a33d2ce-d5a3-1f75-e063-6394a90a0d1b
Set id: 570187da-6747-4da8-b9e3-9a53d5dcdbc3
Version: 9
Effective Time: 20231115
 
Go Smile, Inc.