Label: LUSTER PREMIUM WHITE PRO SONIC DENTAL WHITENING SYSTEM- sodium monofluorophosphate kit

  • 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° C (50-80° F)

  • 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 - Kit Carton

    NEW!

    LUSTER
    PREMIUM WHITE®

    POWER WHITE PRO
    SONIC DENTAL WHITENING SYSTEM

    UP TO 6 SHADES WHITER†

    DEEP SONIC POWER
    WHITENING TECHNOLOGY

    30,000
    VIBRATIONS/MIN.

    3 EASY
    STEPS

    ENAMEL SAFE
    GENTLE & SULFATE-FREE

    POWER SONIC TOOTHBRUSH • 2 AA BATTERIES • 2 BRUSH HEADS
    ACCELERINSE 6 FL OZ (177 mL) • STAIN LIFTING SERUM .25 FL OZ (7 mL)
    POWER WHITE PRO ANTICAVITY FLUORIDE TOOTHPASTE • MINT • NET WT. 1 OZ (28 g)

    SATISFACTION GUARANTEED‡

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    LUSTER PREMIUM WHITE   PRO SONIC DENTAL WHITENING SYSTEM
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-160
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-160-131 in 1 CARTON04/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 28 g
    Part 21 TUBE 177 mL
    Part 31 TUBE 7 mL
    Part 1 of 3
    LUSTER PREMIUM WHITE   POWER WHITE PRO
    sodium monofluorophosphate paste
    Product Information
    Item 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 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35504/01/2018
    Part 2 of 3
    ACCELERINSE 
    dentifrices (aerosol, liquid, pastes, and powders) paste
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRGlycerin (UNII: PDC6A3C0OX)  
    INGRPolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRSodium Bicarbonate (UNII: 8MDF5V39QO)  
    INGRPeppermint Oil (UNII: AV092KU4JH)  
    INGRSodium Carbonate (UNII: 45P3261C7T)  
    INGRBenzalkonium Chloride (UNII: F5UM2KM3W7)  
    INGRSucralose (UNII: 96K6UQ3ZD4)  
    INGRAlcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1177 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC04/01/2018
    Part 3 of 3
    STAIN LIFTING SERUM 
    dentifrices (aerosol, liquid, pastes, and powders) paste
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRAlcohol (UNII: 3K9958V90M)  
    INGRMethyl Hydrogenated Rosinate (UNII: 13DHA19W9N)  
    INGRCarbamide Peroxide (UNII: 31PZ2VAU81)  
    INGRZinc Oxide (UNII: SOI2LOH54Z)  
    INGRHydroxypropyl Cellulose, Unspecified (UNII: 9XZ8H6N6OH)  
    INGRPeppermint Oil (UNII: AV092KU4JH)  
    INGRMenthol, Unspecified Form (UNII: L7T10EIP3A)  
    INGRSucralose (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC04/01/2018
    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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