Label: LUSTER PREMIUM WHITE- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 24, 2020

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  • ACTIVE INGREDIENT

    SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

  • PURPOSE

    ANTICAVITY

  • USE

    HELPS PROTECT AGAINST CAVITIES.

  • WARNINGS

    If you accidentally swallow more than used for brushing, get medical help,

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • DIRECTIONS

    • Adults and children 6 years of age and older—Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by adentist or doctor.
    • Children 6 to 12 years—Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 6 years—Do not use unless directed by dentist or physician.

  • INACTIVE INGREDIENTS

    Sorbitol, Hydrated Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Pvm/Ma Copolymer, Disodium Phosphate, Mica, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Titanium Dioxide, Xanthan Gum, Tetrasodium Pyrophosphate, Hydrolyzed Pearl

  • QUESTIONS

    1-800-823-5272 | French Transit, Ltd., Louisville, CO 80027 USA
    *Visit LusterPremiumWhite.com for more information.

  • PRINCIPAL DISPLAY PANEL

    01b UC_Luster Premium White Pearl_4oz

  • INGREDIENTS AND APPEARANCE
    LUSTER PREMIUM WHITE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-102
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    MICA (UNII: V8A1AW0880)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM ACETATE (UNII: M911911U02)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-102-141 in 1 BOX10/23/2020
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/23/2020
    Labeler - French Transit, Ltd (100044380)
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