Label: ASTONEA -SODIUM FLUORIDE- sodium floride paste, dentifrice
- NDC Code(s): 77338-091-38
- Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 25, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- Do not Swallow
- Supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
- Adults and children 6 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 under 6 years of age: Do not use unless directed by a dentist or physician
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 43 g Tube Carton
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INGREDIENTS AND APPEARANCE
ASTONEA -SODIUM FLUORIDE
sodium floride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-091 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-091-38 43 g in 1 TUBE; Type 0: Not a Combination Product 01/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 01/15/2015 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)