Label: LUSTER PREMIUM WHITE NOW- sodium fluoride paste

  • 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 January 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.24% (w/w)

  • Purpose

    Anticavity

  • 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 6 years of age and olderBrush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor.
    Children 6 to 12 yearsInstruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    Children under 6 yearsDo not use unless directed by a dentist or physician.
  • Other information

    Store between 10-27°C (50°F-80°F)

  • Inactive ingredients

    Sorbitol, Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Disodium Phosphate, PVM/MA Copolymer, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Xanthan Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, FD&C Blue No. 1

  • Questions?

    1-800-823-5272

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Box

    NEW!

    LUSTER
    PREMIUM WHITE®

    NOW!
    INSTANT WHITENING

    ANTICAVITY FLUORIDE
    TOOTHPASTE

    PROVEN EFFECTIVE
    VISIBLY WHITER TEETH
    AFTER JUST 1 BRUSHING

    INSTANT WHITENING

    ENAMEL SAFE
    GENTLE & SULFATE-FREE

    MINT
    NET WT. 4 OZ (113 g)

    SATISFACTION GUARANTEED†

    Principal Display Panel - 113 g Tube Box
  • INGREDIENTS AND APPEARANCE
    LUSTER PREMIUM WHITE   NOW
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-130
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Acesulfame Potassium (UNII: 23OV73Q5G9)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-130-131 in 1 BOX04/01/2018
    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 FINALpart35504/01/2018
    Labeler - French Transit, Ltd. (100044380)
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