Label: ORAL FUSION ANTICAVITY- sodium fluoride paste, dentifrice
- NDC Code(s): 70766-010-01, 70766-010-02
- Packager: Yangzhou SION Commodity Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 8, 2023
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- Active ingredients
- Uses
- Warnings
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Directions
Adult and children 2 years of age and older:
- Brush teeth thoroughly after meal or at least twice a day, or use as directed by a dentist.
- Do not swallow
- To minimizing swallowing, use only a pea sized amount in children under 6
- and supervise children's brushing and rinsing to minimize swallowing.
Under 2 years:
- Ask a dentist
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAL FUSION ANTICAVITY
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.11 g in 100 g Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM (UNII: SB8ZUX40TY) XANTHAN GUM (UNII: TTV12P4NEE) SORBITOL (UNII: 506T60A25R) METHYLPARABEN (UNII: A2I8C7HI9T) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70766-010-01 12 in 1 PACKAGE 04/28/2022 1 24 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70766-010-02 48 in 1 CARTON 04/28/2022 2 24 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 M021 04/28/2022 Labeler - Yangzhou SION Commodity Co.,Ltd (546806042) Registrant - Yangzhou SION Commodity Co.,Ltd (546806042) Establishment Name Address ID/FEI Business Operations Yangzhou SION Commodity Co.,Ltd 546806042 manufacture(70766-010)