Label: AMERFRESH- sodium fluoride paste

  • NDC Code(s): 70766-003-01, 70766-003-02, 70766-003-03, 70766-003-04, view more
    70766-003-05, 70766-003-06, 70766-003-07, 70766-003-08, 70766-003-09, 70766-003-10, 70766-003-11, 70766-003-12, 70766-003-13
  • 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 0.22%(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

    1

  • INGREDIENTS AND APPEARANCE
    AMERFRESH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 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:70766-003-01144 in 1 BOX05/25/2016
    117 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70766-003-02144 in 1 BOX05/25/2016
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70766-003-03144 in 1 BOX05/25/2016
    343 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70766-003-04144 in 1 BOX05/25/2016
    478 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:70766-003-05144 in 1 BOX06/18/2016
    585 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:70766-003-06144 in 1 BOX06/18/2016
    6142 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:70766-003-071000 in 1 BOX06/18/2016
    77 g in 1 BAG; Type 0: Not a Combination Product
    8NDC:70766-003-101000 in 1 BOX06/18/2016
    87.1 g in 1 BAG; Type 0: Not a Combination Product
    9NDC:70766-003-085 in 1 CARTON11/23/2016
    9144 in 1 BOX
    917 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:70766-003-095 in 1 CARTON11/23/2016
    10144 in 1 BOX
    1024 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:70766-003-1172 in 1 BOX06/18/2016
    11142 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:70766-003-1272 in 1 BOX06/18/2016
    12181 g in 1 TUBE; Type 0: Not a Combination Product
    13NDC:70766-003-134 in 1 CARTON12/18/2017
    13125 in 1 BOX
    135 g in 1 TUBE; 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(70766-003)
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