Label: CAVITY PROTECTION FRESH MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 63615-000-01
  • Packager: Oxyfresh Worldwide Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active ingredient

    Sodium fluoride 0.235%

    Purpose

    Anticavity paste

  • Uses

    Helps protect against cavities.

  • Warnings

    For topical application only. Do not swallow.

    Keep out of reach of children

    under six years of age.  

    • Not to be used by children under six, unless recommended by a dentist or physician.
    • If paste is accidentally swallowed, contact a physician or Poison Control Center right away.

    Do not use

    if safety seal is torn or missing.

  • Directions

    Apply a pearl-size drop onto a toothbrush. Gently brush teeth in a circular motion for 2-3 minutes after each meal.

  • Other information

    Store away from direct sunlight.

  • INGREDIENTs

    Sorbitol, Hydrated Silica, Glycerin, Water (Aqua), Sodium Lauryl Sulfate, Chondrus Crispus (Carrageenan), Stabilized Chlorine Dioxide (Oxygene), Sucralose, Zinc Acetate, Titanium Dioxide, Flavor*. Peppermint oil

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    CAVITY PROTECTION FRESH MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63615-000
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    OXYGEN (UNII: S88TT14065)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ZINC ACETATE (UNII: FM5526K07A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63615-000-011 in 1 CARTON05/23/2014
    1142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/23/2014
    Labeler - Oxyfresh Worldwide Inc (103385522)
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