LUSTER PREMIUM WHITE- sodium fluoride gel, dentifrice 
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 PEARL

ACTIVE INGREDIENT

SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY

USE

HELPS PROTECT AGAINST CAVITIES.

WARNINGS

If you accidentally swallow more than used for brushing, get medical help,

Keep out of reach of children under 6 years of age.

DIRECTIONS

INACTIVE INGREDIENTS

Sorbitol, Hydrated Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Pvm/Ma Copolymer, Disodium Phosphate, Mica, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Titanium Dioxide, Xanthan Gum, Tetrasodium Pyrophosphate, Hydrolyzed Pearl

QUESTIONS

1-800-823-5272 | French Transit, Ltd., Louisville, CO 80027 USA
*Visit LusterPremiumWhite.com for more information.

01b UC_Luster Premium White Pearl_4oz

LUSTER PREMIUM WHITE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-102
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
MICA (UNII: V8A1AW0880)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM ACETATE (UNII: M911911U02)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-102-141 in 1 BOX10/23/2020
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 finalpart35510/23/2020
Labeler - French Transit, Ltd (100044380)

Revised: 10/2020
Document Id: 851f0228-e974-4ee8-a28d-3bcc4eacfd25
Set id: b7742579-65c6-4ebf-b369-eeacaefd7da5
Version: 4
Effective Time: 20201024
 
French Transit, Ltd