Label: WHITE GLO PROFESSIONAL WHITE ANTICAVITY- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredient

    Sodium monofluorophosphate0.76% (0.1% W/W fluoride ion).

    Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

    Keep out of reach of children 

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. under 6 years of age.

  • Directions

     Adults and children 2 years of age & older: Brush teeth thoroughly, preferably after each  meal or at least twice a day, 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.

    Consult a dentist or doctor. Children under 2 years of age:

  • Other information

    • Store in a cool place, below 860 F, away from heat • Do not use if quality seal is broken or missing

  • Inactive ingredients

    Calcium Carbonate, Sorbitol, Silica, Aqua (Water), Glycerin, Hydrated Silica Sodium Lauryl Sulfate, Cellulose Gum, Aroma (Flavour), Sodium Benzoate, Hydroxyethylcellulose, Sodium Phytate, Sodium Saccharin, Sodium Bicarbonate (Natural Baking Soda), Phthalimidoperoxycaproic Acid. Hydrogen Peroxide, Bromelain, Sodium Phosphate, Mica.

  • Questions or comments

    For customer enquiries, please contact: customer.service@whiteglo.com White Glo USA INC. 42 West Campbell Avenue, Third Floor Campbell, California 9500. www.whiteglo.com

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    WHITE GLO PROFESSIONAL WHITE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    BROMELAINS (UNII: U182GP2CF3)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-019-001 in 1 TUBE08/20/2023
    1115 g in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/20/2023
    Labeler - WHITE GLO USA INC (117345666)
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