LUSTER PREMIUM WHITE  PRO LIGHT DENTAL WHITENING SYSTEM- sodium monofluorophosphate 
French Transit, Ltd.

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.

----------

Luster Premium White ®
Pro Light Dental Whitening System™

Drug Facts

Active ingredient

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 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 (50-80°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 LOOK!

LUSTER
PREMIUM WHITE®

BONUS
1OZ POWER
WHITE PRO™

PRO LIGHT
DENTAL WHITENING SYSTEM™

6 SHADES IN 30 MINUTES†

CLINICALLY PROVEN
PROFESSIONAL WHITENING TECHNOLOGY

REVERSE YEARS OF
STAINS IN 30 MIN.

3 EASY
STEPS

ENAMEL SAFE
GENTLE & SULFATE-FREE

DUAL-ENERGY WHITENING LIGHT • 4 AAA BATTERIES
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
LUSTER PREMIUM WHITE   PRO LIGHT DENTAL WHITENING SYSTEM
sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-170
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-170-131 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 Form (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)

Revised: 8/2019
Document Id: a8d042d6-24f2-40bc-9050-568f428dcdbb
Set id: 235a44e1-8ef0-4310-9055-7c4eb9c319c2
Version: 1
Effective Time: 20190822
 
French Transit, Ltd.