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

  • NDC Code(s): 10056-530-06, 10056-530-65
  • Packager: Access Business Group, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Sodium fluoride 0.21%

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities

  • Warning

    If more than used for brushing is accidentally swallowed, get medical help or contact  a Poison Control Center right away.

    Keep out of reach of children

    under 6 years of age

  • Directions

    • Do not swallow
    • Adults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor
    • Instruct children under 6 years in good rinsing habits (to reduce swallowing)
    • Supervise children as necessary until capable of using without supervision
    • Children under 2 years, ask a dentist or doctor.
  • Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

    With regular brushing, glister multi-action fluoride toothpaste helps remove plaque. This product contains SYLODENT polishing agent which safely cleans and helps eliminate stains to whiten teeth. To enhance your overall oral health, use the complete glister oral care system

    Trademark is used by Access under license.

  • PRINCIPAL DISPLAY PANEL

    Dist. by Access Business Group International LLC, Ada, MI 49355

    Glister multi-action fluoride toothpaste

    Multiple action

    whitens teeth

    removes plaque

    fights cavities

    safely cleans

    freshens breath

    promotes remineralization

    MADE IN U.S.A.


  • Package Labeling: 10056-530-06

    191Label06

  • Package Labeling: 10056-530-65

    65Label65

  • INGREDIENTS AND APPEARANCE
    GLISTER MULTI-ACTION FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-530
    Route of AdministrationTOPICAL
    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 (UNII: K679OBS311)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10056-530-651 in 1 BOX04/11/2011
    165 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10056-530-061 in 1 BOX04/11/2011
    2191 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 DrugM02104/11/2011
    Labeler - Access Business Group, LLC (839830713)