LUSTER PREMIUM WHITE  AM/PM- sodium fluoride and 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.

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Luster Premium White®
AM/PM

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 olderBrush 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 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

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

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 olderBrush teeth thoroughly, preferably after each meal, at least once daily at night, 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!

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‡

PRINCIPAL DISPLAY PANEL - Kit Carton
LUSTER PREMIUM WHITE   AM/PM
sodium fluoride and sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-120
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-120-131 in 1 CARTON04/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 113 g
Part 21 TUBE 113 g
Part 1 of 2
AM 
sodium fluoride paste
Product Information
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1113 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 2
PM 
sodium monofluorophosphate paste
Product Information
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
1113 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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/2018
Labeler - French Transit, Ltd. (100044380)

Revised: 9/2019
Document Id: 0a88d65d-df05-4396-b49a-723a4c803dd2
Set id: 94542fbc-fab4-4709-9741-7dcfca253ba2
Version: 2
Effective Time: 20190920
 
French Transit, Ltd.