LUSTER PREMIUM WHITE  NOW- sodium fluoride paste 
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®
Now!

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 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°F-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

Questions?

1-800-823-5272

PRINCIPAL DISPLAY PANEL - 113 g Tube Box

NEW!

LUSTER
PREMIUM WHITE®

NOW!
INSTANT WHITENING

ANTICAVITY FLUORIDE
TOOTHPASTE

PROVEN EFFECTIVE
VISIBLY WHITER TEETH
AFTER JUST 1 BRUSHING

INSTANT WHITENING

ENAMEL SAFE
GENTLE & SULFATE-FREE

MINT
NET WT. 4 OZ (113 g)

SATISFACTION GUARANTEED

Principal Display Panel - 113 g Tube Box
LUSTER PREMIUM WHITE   NOW
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-130
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 (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
1NDC:72805-130-131 in 1 BOX04/01/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/2018
Labeler - French Transit, Ltd. (100044380)

Revised: 1/2022
Document Id: d0154c38-0b82-4cd7-a5a6-418c821ad0df
Set id: 98a4cb86-7da9-48b3-8939-61f8bb514e07
Version: 4
Effective Time: 20220112
 
French Transit, Ltd.