Label: AMERFRESH TOOTHPOWDER- sodium fluoride powder

  • NDC Code(s): 85162-007-01, 85162-007-02
  • Packager: Yangzhou ONE & ONLY Personal Care Products Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 13, 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 under 6 years of age.

  • Directions

    For Use:

    • Wet toothbrush and dip into powder until brush is fully covered. 
    • Brush teeth and gum line for tleast 30 seconds, rinse and spit out thoroughly
    • 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, silica,sodium lauryl sulfate, flavor, sodium sacharine, methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AMERFRESH TOOTHPOWDER 
    sodium fluoride powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85162-007
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85162-007-0140 in 1 CARTON08/13/2025
    1454 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:85162-007-024 in 1 CARTON08/13/2025
    250 in 1 BOX
    257 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/13/2025
    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(85162-007)
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