LUSTER PREMIUM WHITE AM/PM- sodium fluoride and 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

AM TOOTHPASTE

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 older: Brush teeth thoroughly, preferably after each meal, at least once daily in the morning, 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

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

SPL UNCLASSIFIED SECTION

PM TOOTHPASTE

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 older: Brush teeth thoroughly, preferably after each meal, at least once daily at night, 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®

AM | PM
TOOTHPASTE REINVENTED

3X WHITER IN 3 DAYS†

FRESHER BREATH

INSTANTLY WHITER TEETH

FIGHT CAVITIES

REMOVE DEEP STAINS

WHITEN INSIDE & OUT

STRONGER ENAMEL

PROVEN EFFECTIVE
PROFESSIONAL WHITENING TECHNOLOGY

ENAMEL SAFE / ZERO TOOTH SENSITIVITY

ANTICAVITY FLUORIDE TOOTHPASTE MINT
AM NET WT. 4 OZ (113 g) | PM NET WT. 4 OZ (113 g)

SATISFACTION GUARANTEED‡

INGREDIENTS AND APPEARANCE

LUSTER PREMIUM WHITE   AM/PM
sodium fluoride and sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-120

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-120-13	1 in 1 CARTON	04/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	113 g
Part 2	1 TUBE	113 g

Part 1 of 2

AM 
sodium fluoride paste

Product Information
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 form (UNII: K679OBS311)
Sodium Benzoate (UNII: OJ245FE5EU)
Acesulfame Potassium (UNII: 23OV73Q5G9)
Titanium Dioxide (UNII: 15FIX9V2JP)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Pyrophosphate (UNII: O352864B8Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		113 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 2

PM 
sodium monofluorophosphate paste

Product Information
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		113 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

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)