Label: WHITE GLO INSTANT WHITE- sodium monofluorophosphate kit

  • NDC Code(s): 73656-015-00, 73656-016-00
  • 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 pretect 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 rightaway. 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.

    Children under 2 years of age: 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 (Aqua), Sodium Lauryl Sulfate, Polyethylene Glycol 400, Flavor, Xylitol, Sodium Benzoate, Tetrasodium Pyrophosphate, Cellulose Gum, Mica, FD&C Blue No.1

  • Questions or comments

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

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    WHITE GLO INSTANT WHITE 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-015
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-015-001 in 1 KIT11/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 150 g
    Part 1 of 1
    WHITE GLO INSTANT WHITE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-016
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.001 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICA (UNII: V8A1AW0880)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-016-001 in 1 CARTON
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/01/2021
    Labeler - WHITE GLO USA INC (117345666)
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