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
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Active ingredients

    Sodium Fluoride 0.243%

    Purpose

    anticavity

  • Uses

    Help protect against cavities

  • Warnings

    Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

    Keep out of reach of children.

  • 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

    Sorbitol, Water, Hydrated Silica, Disodium pyrophosphate, Flavor, Sodium Hydroxide, Xanthan Gum, Cellulose Gum, Hydroxypropyl Guar, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Water, Sodium Lauryl Sulfate, CI 778891

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ORAL FUSION ANTICAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70766-010-0112 in 1 PACKAGE04/28/2022
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70766-010-0248 in 1 CARTON04/28/2022
    224 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/28/2022
    Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
    Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-010)
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