Label: THERABREATH OVERNIGHT CHAMOMILE MINT- sodium fluoride rinse

  • NDC Code(s): 10237-262-16
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sodium Fluoride 0.05% (0.02% wh fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, gel medical help or contact a Poison Control Center right away.

    Do not use with another fluoride rinse on the same day.

  • Directions

    Adults 18 years of age or older:

    • Use once a day atter 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.
  • Other information

    Do not use if safety seal is broken or missing

  • Inactive Ingredients

    Water, Flavor, Citric Acid, Glycerin, Menthol, PEG-40 Hydrogenated Castor Oil, Sodium Benzoate, Sodium Bicarbonate, Sodium Chlorite, Sodium Hydroxide, Sucralose

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    ANTICAVITY FLUORIDE RINSE

    STRENGTHENS
    TEETH

    TheraBreath™
    DENTIST FORMULATED
    OVERNIGHT
    ORAL RINSE

    FIGHTS BAD BREATH FOR 12 HOURS*
    HELPS PREVENT CAVITIES & REBUILD ENAMEL

    No Alcohol • No Dyes
    Non Burning

    IMPORTANT:
    Read directions
    for proper use.

    16 fl. oz.
    473 mL

    CHAMOMILE MINT

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    THERABREATH OVERNIGHT CHAMOMILE MINT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-262
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMENTHOL, MINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-262-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02201/22/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
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