Label: AMERFRESH FLUORIDE GEL- sodium fluoride paste, dentifrice

  • NDC Code(s): 70766-008-01, 70766-008-02, 70766-008-03, 70766-008-04, view more
    70766-008-05, 70766-008-06, 70766-008-07
  • Packager: Yangzhou SION Commodity Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Active ingredients

    Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

    Purpose

    anticavity toothpaste

  • Uses

    Aids in the prevention of dental 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

    • do not swallow
    • supervise children as necessary until capable of useing 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 a physician.
    • Children under 6 years of age:do not use unless directed by a doctor or dentist.
  • INACTIVE INGREDIENT

    Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Glycerin, anthan Gum, Sodium Benzoate, Cetylpyridinium Chloride.    

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AMERFRESH FLUORIDE GEL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70766-008-01144 in 1 BOX02/28/2022
    117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70766-008-02144 in 1 BOX02/28/2022
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70766-008-03144 in 1 BOX02/28/2022
    343 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70766-008-04144 in 1 BOX02/28/2022
    478 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:70766-008-05144 in 1 BOX02/28/2022
    585 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:70766-008-06144 in 1 BOX02/28/2022
    6142 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:70766-008-071000 in 1 BOX02/28/2022
    77 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/28/2022
    Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
    Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-008)
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