Label: AMERFRESH- sodium fluoride paste

  • NDC Code(s): 70766-001-01, 70766-001-02, 70766-001-03, 70766-001-04, view more
    70766-001-05, 70766-001-06, 70766-001-07
  • Packager: Yangzhou SION Commodity Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Active ingredients

    Sodium monofluorophosphate 0.76%(0.1 w/v Fluoride ion)

    Purpose

    anticavity

  • 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,water,sorbitol,hydrated silica,sodium lauryl sulfate,sodium carboxymethyl cellulose,flavor,sodium sacharine,polymethylene glycol,guar gum,methylisothiazolinone.

  • PRINCIPAL DISPLAY PANEL

    a

  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GUAR GUM (UNII: E89I1637KE)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    METHYLENE GLYCOL (UNII: 6Z20YM9257)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70766-001-01144 in 1 BOX05/25/2016
    117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70766-001-02144 in 1 BOX05/25/2016
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70766-001-03144 in 1 BOX05/25/2016
    343 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70766-001-04144 in 1 BOX05/25/2016
    478 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:70766-001-05144 in 1 BOX06/18/2016
    585 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:70766-001-06144 in 1 BOX06/18/2016
    6142 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:70766-001-071000 in 1 BOX06/18/2016
    77 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/01/2016
    Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
    Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-001)
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