Label: THERABREATH FOR KIDS ANTI CAVITY 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 3, 2022

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  • Active Ingredient

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

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    Keep Out Of Reach of Children.

  • Warnings

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

  • 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, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

  • TheraBreath Kids Anti Cavity Oral Rinse

    Kids Anti Cavity Oral Rinse Label

  • INGREDIENTS AND APPEARANCE
    THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-254
    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
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPE (UNII: 6X543N684K)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape (Organic)) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72551-254-01473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/01/2018
    Labeler - Dr. Harold Katz, LLC (965507767)
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