Label: AMERFRESH- sodium fluoride paste

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 3, 2020

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  • Active Ingredients

    Sodium fluoride-0.22%

  • 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 right away.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • 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.
    •  Do not swallow.
    • To minimize the swallowing ,use a pea-sized amount in children under 6 years old.
    • Supervise children’s brushing until good habits are established.
    • Children under 2 yrs : ask a dentist before use
  • Inactive Ingredients

    Calcium Carbonate, Water,Sorbitol,Hydrated Silica, Sodium Lauryl Sulphate,Sodium Carboxymethyl cellulose, Flavor, Sodium Saccharin, Sodium methyl paraben, Sodium propyl paraben.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:73398-114
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73398-114-017.1 g in 1 POUCH; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2020
    Labeler - SUHAN AEROSOL (861140760)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUHAN AEROSOL861140760manufacture(73398-114)
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