Label: ADOPTAPLATOON- sodium fluoride paste, dentifrice

  • NDC Code(s): 85162-004-01, 85162-004-02
  • Packager: Yangzhou ONE & ONLY Personal Care Products Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 21, 2025

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  • Active ingredients

    Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

    Purpose

    anticavity

  • Uses

    Help protect against 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

    Adult and children six years of age or older:

    • Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician. 

    Children 2-6:

    • Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing.

    Children under 2:

    • Ask a dentist or physician
  • INACTIVE INGREDIENT

    Sorbitol, Silica,Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavor, Water, SCMC, Sodium Lauryl Sulfate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ADOPTAPLATOON 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85162-004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85162-004-0230 in 1 BOX03/20/2025
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:85162-004-0110 mL in 1 TUBE; Type 0: Not a Combination Product03/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/20/2025
    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(85162-004)
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