GLO SCINECE ANTIOXIDANT- fluoride paste, dentifrice 
GLO Science 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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Drug Facts

Active ingredients

Active Ingredient: SODIUM MONOFLUOROPHOSPHATE 0.84% FLUORIDE ION                 PURPOSE: ANTICAVITY

Use

Uses

aids in the prevention of dental cavities

Keep out of reach of children

Keep out of reach of children under 6 years of age

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably
after each meal or at least twice a day or as recommended by a dentist or doctor.
Children 2 to 6 years: Use a pea sized amount (to minimize swallowing), supervise until good
brushing habits are established. Children under 2 years of age:Consult a dentist or doctor.

Inactive ingredients


Inactive ingredients:
Water, sorbitol, glycerin, hydrated silica, xylitol, titanium dioxide, Cocamidopropyl Betaine, Sodium Methyl Cocoyl Taurate, Flavor, Maltodextrin, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Vitis Vinifera (Grape) Seed Extract, Helianthus Annuus (Sunflower) Oil, Acacia Senegal Gum, Ubiquinone (Coenzyme Q10), White Cranberry Juice Concentrate,  Stevia Rebaudiana Extract, Cellulose Gum, Xanthan Gum, Zinc Lactate, Folic Acid, Ammonium Glycyrrhizinate, Gelatin, Potassium Sorbate, Sodium Hydroxide, FDC Red 30

image of tube label

image of carton label

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing

is accidentally swallowed, get medical help or contact a poison control center immediately.

GLO SCINECE  ANTIOXIDANT
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49993-860
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.84 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ZINC LACTATE (UNII: 2GXR25858Y)  
FOLIC ACID (UNII: 935E97BOY8)  
CRANBERRY (UNII: 0MVO31Q3QS)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
UBIDECARENONE (UNII: EJ27X76M46)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GELATIN (UNII: 2G86QN327L)  
ACACIA (UNII: 5C5403N26O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorred (red 30) Score    
ShapeSize
FlavorMINT (Hagelin 623097 N&A Berry Mint Flavor O.S.) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49993-860-091 in 1 CARTON
1NDC:49993-860-02141.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2012
Labeler - GLO Science Inc (961623019)

Revised: 5/2012
Document Id: a6232b52-e181-42a1-9140-b096cf7dd43f
Set id: 460f1603-e3c3-48cc-80f6-ff9e59c4a17e
Version: 4
Effective Time: 20120511
 
GLO Science Inc