Label: THERABREATH ANTICAVITY- sodium fluoride rinse

  • NDC Code(s): 10237-260-01, 10237-260-03, 10237-260-16
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 14, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sodium Fluoride 0.05% (0.02% w/v 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, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and Children 18 years of age or 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.
  • 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.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    FORMERLY
    KNOWN AS
    HEALTHY
    SMILE

    ANTICAVITY FLUORIDE RINSE

    Thera Breath™
    DENTIST FORMULATED
    ANTICAVITY
    ORAL RINSE

    HELPS FIGHT CAVITIES FOR 24 HOURS*
    STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH

    Helps rebuild weakened tooth enamel and prevent tooth decay

    No Alcohol • With Fluoride • Non Burning

    IMPORTANT:
    Read directions
    for proper use.

    16 fl.oz.
    473 mL

    SPARKLE MINT

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    THERABREATH ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-260
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.005 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)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-260-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    2NDC:10237-260-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    3NDC:10237-260-0388.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02102/13/2023
    Labeler - Church & Dwight Co., Inc. (001211952)
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