Label: LUSTER PREMIUM WHITE- sodium fluoride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72805-201-14 - Packager: French Transit, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 24, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
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INGREDIENTS AND APPEARANCE
LUSTER PREMIUM WHITE
sodium fluoride gel, dentifriceProduct 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)