Label: TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT CAVITY PROTECTION / WHITENING- sodium fluoride paste, dentifrice
- NDC Code(s): 51009-218-21, 51009-218-40, 51009-218-75
- Packager: Tom's of Maine, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- active ingredient
- purpose
- use
- warnings
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directions
adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). children under 2 years: ask a dentist or physician.
- inactive ingredients
- PRINCIPAL DISPLAY PANEL - 113 g Tube Label
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INGREDIENTS AND APPEARANCE
TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT CAVITY PROTECTION / WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-218 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00243 g in 1 g Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PEPPERMINT OIL (UNII: AV092KU4JH) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARRAGEENAN (UNII: 5C69YCD2YJ) Product Characteristics Color WHITE Score Shape Size Flavor PEPPERMINT (Clean Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-218-75 1 in 1 CARTON 10/20/2017 12/29/2023 1 21 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51009-218-40 1 in 1 CARTON 11/13/2018 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51009-218-21 21 g in 1 TUBE; Type 0: Not a Combination Product 07/25/2018 11/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M021 12/01/2015 Labeler - Tom's of Maine, Inc. (052764354) Registrant - Tom's of Maine, Inc. (829517189)