Label: GLISTER MULTI-ACTION- sodium fluoride paste, dentifrice

  • NDC Code(s): 10056-415-00, 10056-415-01
  • Packager: Access Business Group LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.21%

    Purpose

    Anticavity

  • Use

    Aids in the prevention of dental 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 immediately. under 6 years of age.

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    • Instruct children under 6 years of age 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.

  • Inactive Ingredients

    Water, Sorbitol, Hydrated Silica, Glycerin, Propylene Glycol, Sodium Lauryl Sulfate, Xylitol, Cellulose Gum, PEG-8, Flavor, Titanium Dioxide, Sodium Benzoate, Xanthan Gum, Sodium Saccharin, Blue No. 1

  • Package Labeling:50g

    Label50g

  • Package Labeling:200g

    Label200g

  • INGREDIENTS AND APPEARANCE
    GLISTER MULTI-ACTION 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-415
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-415-001 in 1 CARTON03/22/2023
    150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10056-415-011 in 1 CARTON03/22/2023
    2200 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/22/2023
    Labeler - Access Business Group LLC (839830713)
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