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

Luster Premium White by

Drug Labeling and Warnings

Luster Premium White by is a Otc medication manufactured, distributed, or labeled by French Transit, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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‡

INGREDIENTS AND APPEARANCE

LUSTER PREMIUM WHITE   PRO SONIC DENTAL WHITENING SYSTEM
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-160

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-160-13	1 in 1 CARTON	04/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	28 g
Part 2	1 TUBE	177 mL
Part 3	1 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 Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.88 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-150-28	28 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	04/01/2018

Part 2 of 3

ACCELERINSE 
dentifrices (aerosol, liquid, pastes, and powders) paste

Product Information
Route of Administration	DENTAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Sodium Bicarbonate (UNII: 8MDF5V39QO)
INGR	Peppermint Oil (UNII: AV092KU4JH)
INGR	Sodium Carbonate (UNII: 45P3261C7T)
INGR	Benzalkonium Chloride (UNII: F5UM2KM3W7)
INGR	Sucralose (UNII: 96K6UQ3ZD4)
INGR	Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		177 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		04/01/2018

Part 3 of 3

STAIN LIFTING SERUM 
dentifrices (aerosol, liquid, pastes, and powders) paste

Product Information
Route of Administration	DENTAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Alcohol (UNII: 3K9958V90M)
INGR	Methyl Hydrogenated Rosinate (UNII: 13DHA19W9N)
INGR	Carbamide Peroxide (UNII: 31PZ2VAU81)
INGR	Zinc Oxide (UNII: SOI2LOH54Z)
INGR	Hydroxypropyl Cellulose, Unspecified (UNII: 9XZ8H6N6OH)
INGR	Peppermint Oil (UNII: AV092KU4JH)
INGR	Menthol, Unspecified Form (UNII: L7T10EIP3A)
INGR	Sucralose (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	04/01/2018

Labeler - French Transit, Ltd. (100044380)