Label: AMERFRESH FLUORIDE- sodium fluoride paste, dentifrice

  • NDC Code(s): 85162-002-01, 85162-002-02, 85162-002-03, 85162-002-04, view more
    85162-002-05, 85162-002-06, 85162-002-07
  • Packager: Yangzhou ONE & ONLY Personal Care Products Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 16, 2025

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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

    Calcium Carbonate, Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Hydroypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben 

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AMERFRESH FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85162-002
    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)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85162-002-01144 in 1 BOX01/16/2025
    117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:85162-002-02144 in 1 BOX01/16/2025
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:85162-002-03144 in 1 BOX01/16/2025
    343 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:85162-002-04144 in 1 BOX01/16/2025
    478 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:85162-002-05144 in 1 BOX01/16/2025
    585 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:85162-002-06144 in 1 BOX01/16/2025
    6142 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:85162-002-071000 in 1 BOX01/16/2025
    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 DrugM02101/16/2025
    Labeler - Yangzhou ONE & ONLY Personal Care Products Co., LTD (458091296)
    Registrant - Yangzhou ONE & ONLY Personal Care Products Co., LTD (458091296)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou ONE & ONLY Personal Care Products Co., LTD458091296manufacture(85162-002)
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