Label: MINT FLUORIDE TOOTH- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 70766-011-02, 70766-011-03, 70766-011-04, 70766-011-05, view more
    70766-011-06, 70766-011-07
  • 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%(0.11 w/v Fluoride ion)

    Purpose

    Anti-cavity toothpaste

  • Uses

    aids in the prevention of cavities.

  • Warnings

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

    Do not use if the inner foil is torn, cut, or missing

    Keep out of reach of children.

  • Directions

    Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician

    Do not swallow

    To minimize wallowing, use a pea sizes amount in children under 6 years

    Supervise children's brushing

  • INACTIVE INGREDIENT

    Sorbitol, Hydrated silica,Water, PEG-8, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Menthol, Dicalcium Phosphate, Methylparaben, Propylparaben, Titanium Dioxide, sodium sacharine

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MINT FLUORIDE TOOTH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-011
    Route of AdministrationDENTAL
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MENTHOL (UNII: L7T10EIP3A)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70766-011-074 in 1 BOX12/10/2022
    112 in 1 POUCH
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70766-011-0212 in 1 BOX12/10/2022
    212 in 1 POUCH
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70766-011-0324 in 1 BOX12/10/2022
    312 in 1 POUCH
    324 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70766-011-04144 in 1 BOX12/10/2022
    424 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:70766-011-05288 in 1 BOX12/10/2022
    524 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:70766-011-06576 in 1 BOX12/10/2022
    624 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/13/2022
    Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
    Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-011)
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