Label: THERABREATH HEALTHY SMILE ORAL RINSE- sodium fluoride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 4, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities

  • Warnings

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Warnings

  • Directions

    Adults and Children 6 years of age and older:

    • Use once a day after brushing your teeth with a toothpaste.
    • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
    • Do not swallow the rinse.
    • Do not eat or drink for 30 minutes after rinsing.
    • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
    • Children under 6 years of age: consult a dentist or doctor.

  • Other Information

    Do not use if safety seal is broken or missing.

  • Inactive Ingredients

    Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Citric Acid, Sodium Hydroxide, Sodium Chlorite, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate.

  • TheraBreath Healthy Smile Oral Rinse

    Healthy Smile Oral Rinse

  • Healthy Smile Travel Size

    Travel Size

  • Healthy Smile Travel Pouch 0.25 oz

    Healthy Smile Travel Pouch 0.25 oz

  • INGREDIENTS AND APPEARANCE
    THERABREATH HEALTHY SMILE ORAL RINSE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-246
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL (UNII: I9GRO824LL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72551-246-01473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    2NDC:72551-246-0285 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    3NDC:72551-246-037 g in 1 POUCH; Type 0: Not a Combination Product03/19/2019
    4NDC:72551-246-04958.21 g in 1 BOTTLE; Type 0: Not a Combination Product10/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/02/2018
    Labeler - Dr. Harold Katz, LLC (965507767)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!