Label: CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH- sodium fluoride mouthwash

  • NDC Code(s): 63615-001-01, 63615-001-02
  • 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 0.05%

    Purpose

    Anticavity rinse

  • Uses

    Helps protect against cavities.

  • Warnings

    For rinsing 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 more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away.

    Do not use

    if safety seal is torn or missing.

  • Directions

    Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.

  • Other information

    Store away from direct sunlight.

  • INGREDIENTs

    Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid.

    *Contains Peppermint Essential Oil

  • Package Labeling:473ml

    Outer Package2

  • Package Labeling:3.8 L

    Label

  • INGREDIENTS AND APPEARANCE
    CAVITY PROTECTION FRESH MINT ANTICAVITY MOUTHWASH 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63615-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORINE DIOXIDE (UNII: 8061YMS4RM)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    OXYGEN (UNII: S88TT14065)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63615-001-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/23/2014
    2NDC:63615-001-023800 mL in 1 JUG; Type 0: Not a Combination Product05/23/2014
    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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