Label: WHITE GLO CHARCOAL- sodium monofluorophosphate kit

  • NDC Code(s): 73656-009-00, 73656-010-00
  • Packager: WHITE GLO USA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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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 & older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
     Children under 2 years  Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary.
     Children 2 to 6 years Consult a dentist or doctor.

  • 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

    Sorbitol, Hydrated Silica, Water, Glycerine, Sodium Lauryl Sulphate, Flavor, Charcoal, Cellulose Gum, Chondrus Crispus, Tetrasodium Pyrophosphate, Sodium Saccharin, Sodium Benzoate

  • 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:

    LabelBox

  • INGREDIENTS AND APPEARANCE
    WHITE GLO CHARCOAL 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-009
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-009-001 in 1 KIT03/16/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 150 g
    Part 1 of 1
    WHITE GLO CHARCOAL 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-010
    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
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-010-00150 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 DrugM02103/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/16/2020
    Labeler - WHITE GLO USA INC (117345666)
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