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

ACTIVE INGREDIENT

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

PURPOSE

ANTI-CAVITY

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

Glycerin, Sorbitol, Hydrated Silica, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mica, Titanium Dioxide, Charcoal Powder, Mentha Arvensis (Cornmint) Leaf Oil, Menthol, Vanilla Planifolia Fruit Extract

QUESTIONS

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

01b UC_Luster Premium White_4oz

LUSTER PREMIUM WHITE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-201
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
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
TEA TREE OIL (UNII: VIF565UC2G)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
MENTHOL (UNII: L7T10EIP3A)  
VANILLA BEAN (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-201-141 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: 59586abd-512c-42c6-a74d-fda87ce8fd33
Set id: e29f8a27-3a2f-4a48-9619-5154cbd9d406
Version: 5
Effective Time: 20201024
 
French Transit, Ltd.