Label: XEROSTOM- sodium fluoride paste
- NDC Code(s): 61041-212-01
- Packager: Bio Cosmetics S L
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 25, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose Section
- Keep out of reach of children
- Indications & Usage Section
- Warnings
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Dosage and administration
Adults and children over 12 years apply toothpaste onto a soft bristle toothbrush brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.
Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good
habits are established. - Inactive Ingredient
- Principal Display panel
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INGREDIENTS AND APPEARANCE
XEROSTOM
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61041-212 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.2 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) XYLITOL (UNII: VCQ006KQ1E) BETAINE (UNII: 3SCV180C9W) POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G) OLIVE OIL (UNII: 6UYK2W1W1E) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PAPAIN (UNII: A236A06Y32) PARSLEY OIL (UNII: IXK9N7RJ7J) DEXPANTHENOL (UNII: 1O6C93RI7Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61041-212-01 1 in 1 CARTON 11/08/2013 04/30/2025 1 64 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 11/08/2013 04/30/2025 Labeler - Bio Cosmetics S L (513423178) Establishment Name Address ID/FEI Business Operations LABORATORIOS COSMODENT SL 513012153 manufacture(61041-212)