Label: WHITE GLO INSTANT WHITE BLUE FOAM OPTICAL ENHANCERS FLUORIDE ANTICAVITY VALUE 2 PACK AND TOOTHBRUSH- sodium monofluorophosphate kit

  • NDC Code(s): 73656-028-00, 73656-029-00
  • Packager: WHITE GLO USA INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 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 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, Flavour, Xylitol, Sodium Benzoate, Trisodium Phosphate, Cellulose Gum, Mica, FD&C Blue No. 1.

  • Questions or comments

    For customer enquiries, please contact: customer.service@whiteglo.com

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    WHITE GLO INSTANT WHITE BLUE FOAM OPTICAL ENHANCERS FLUORIDE ANTICAVITY VALUE 2 PACK AND TOOTHBRUSH 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73656-028
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-028-001 in 1 KIT05/30/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 TUBE 300 g
    Part 1 of 1
    BLUE INSTANT WHITE WITH BLUE FOAM OPTICAL ENHANCERS FLUORIDE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:73656-029
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    MICA (UNII: V8A1AW0880)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73656-029-00150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/30/2024
    Labeler - WHITE GLO USA INC (117345666)
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