Label: BIOTENE- sodium monofluorophosphate paste
- NDC Code(s): 0135-0577-01
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 15, 2023
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- Active ingredient
- Purpose
- Use
- Warnings
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Directions
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adults and children 2 years of age and older:
- apply toothpaste onto a toothbrush
- brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing.
- to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
- children under 2 years of age:Consult a dentist or doctor.
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adults and children 2 years of age and older:
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
BIOTENE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0577 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) ISOCETETH-20 (UNII: O020065R7Z) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM BENZOATE (UNII: OJ245FE5EU) CALCIUM LACTATE (UNII: 2URQ2N32W3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0577-01 1 in 1 CARTON 09/01/2016 1 121.9 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 Drug M022 09/01/2016 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)