Label: LUSTER PREMIUM WHITE POWER WHITE PRO- sodium monofluorophosphate paste

  • NDC Code(s): 72805-140-13, 72805-150-28
  • Packager: French Transit, Ltd.
  • 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 Ingredients

    Sodium Monofluorophosphate 0.88% (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 older

    Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist 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 a dentist or physician

  • Other information

    Store between 10-27 degrees Celsius (50-80 degrees Fahrenheit)

  • Inactive ingredients

    Vegetable Glycerin, Calcium Pyrophosphate, Zea Mays (Corn) Starch, Propylene Glycol, PEG-12, Water, Hydrogen Peroxide, Sodium Lauroyl, Sarcosinate, Flavor, Cellulose Gum, Carbomer, Sodium Saccharin, Butylated Hydroxytoluene

  • Questions?

    1-800-823-5272

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Box

    NEW!

    LUSTER
    PREMIUM WHITE®

    POWER
    WHITE PRO
    DEEP STAIN ERASER®

    ANTICAVITY FLUORIDE
    TOOTHPASTE

    PROVEN EFFECTIVE
    TO REMOVE UP TO 95%
    OF SURFACE STAINS
    IN 5 DAYS†

    DAILY CARE + WHITENING

    ENAMEL SAFE
    GENTLE & SULFATE-FREE

    MINT
    NET WT. 4 OZ (113 g)

    SATISFACTION GUARANTEED‡

    PRINCIPAL DISPLAY PANEL - 113 g Tube Box
  • PRINCIPAL DISPLAY PANEL - 28 g Tube Label

    LUSTER
    PREMIUM WHITE®

    POWER
    WHITE PRO™
    DEEP STAIN ERASER®

    ANTICAVITY FLUORIDE
    TOOTHPASTE

    PROVEN EFFECTIVE
    TO REMOVE UP TO 95% OF
    SURFACE STAINS IN 5 DAYS†

    DAILY CARE + WHITENING

    ENAMEL SAFE
    ZERO SENSITIVITY

    MINT
    NET WT. 1 OZ (28 g)

    SATISFACTION GUARANTEED

    PRINCIPAL DISPLAY PANEL - 28 g Tube Label
  • INGREDIENTS AND APPEARANCE
    LUSTER PREMIUM WHITE   POWER WHITE PRO
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-140
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.88 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Calcium Pyrophosphate (UNII: X69NU20D19)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-140-131 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
    LUSTER PREMIUM WHITE   POWER WHITE PRO
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-150
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.88 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Calcium Pyrophosphate (UNII: X69NU20D19)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    Hydrogen Peroxide (UNII: BBX060AN9V)  
    Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-150-2828 g in 1 TUBE; Type 0: Not a Combination Product04/01/2018
    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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