LUSTER PREMIUM WHITE- sodium fluoride gel, dentifrice

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]

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

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

DIRECTIONS

• Adults and children 6 years of age and older—Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by adentist 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 dentist or physician.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUSTER PREMIUM WHITE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-201
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-201-14	1 in 1 BOX	10/23/2020
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/23/2020

Labeler - French Transit, Ltd. (100044380)