Label: WHITE GLO MICELLAR- sodium monofluorophosphate kit

  • NDC Code(s): 73656-003-00, 73656-004-00
  • Packager: WHITE GLO USA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.1% W/V fluoride ion)

    Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • 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 right away.

  • 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 86°F, away from heat 
    • Do not use if quality seal is broken or missing
  • Inactive ingredients

    Calcium carbonate, water, sorbitol, glycerin, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, cocamidopropyl betaine, propylene glycol, FD&C Red 40

  • Questions or comments

    For customer enquiries, please contact: customer.enquiry@whiteglo.com White Glo USA INC.25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    WHITE GLO MICELLAR 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-003
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-003-001 in 1 KIT02/15/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 150 g
    Part 1 of 1
    WHITE GLO MICELLAR 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-004-00150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/15/2020
    Labeler - WHITE GLO USA INC (117345666)
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