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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 7, 2023

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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 not finalpart35602/28/2022
    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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