Label: WHITE GLO MOUTHWASH PROTECTION- sodium monofluorophosphate kit

  • NDC Code(s): 73656-017-00, 73656-018-00
  • 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 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

    Calcium Carbonate, Water, Sorbitol, Glycerin, Silica, Alcohol, Sodium Lauryl Sulfate, Flavor, Carrageenan, Cellulose Gum, Hydroxyethylcellulose, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Thymol, Rosa Canina Fruit Oil

  • 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 Package3Inner Package3

  • INGREDIENTS AND APPEARANCE
    WHITE GLO MOUTHWASH PROTECTION 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-017
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-017-001 in 1 KIT11/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 150 g
    Part 1 of 1
    WHITE GLO MOUTHWASH PROTECTION 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-018
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    THYMOL (UNII: 3J50XA376E)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-018-001 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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