Label: GLO SCINECE ANTIOXIDANT- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 11, 2012

If you are a consumer or patient please visit this version.

  • Active ingredients

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

    • aids in the prevention of dental cavities
  • 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
  • PRINCIPAL DISPLAY PANEL

    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.

  • INGREDIENTS AND APPEARANCE
    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)