Label: THERABREATH PLAQUE CONTROL- cetylpyridinium chloride rinse

  • NDC Code(s): 10237-259-16
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Cetylpyridinium Chloride 0.075%

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

    • Helps prevent gingivitis, an early form of gum disease and bleeding gums
    • Helps control plaque that leads to gingivitis and bleeding gums
  • Warnings

    Stop use and ask a dentist if

    • Gingivitis, bleeding, or redness persists for more than 2 weeks.
    • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and Children 12 years and olderVigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
    Children 6 years to under 12 yearsSupervise use.
    Children under 6 yearsDo not use.
  • Other information

    This rinse is not intended to replace brushing or flossing.

  • Inactive Ingredients

    Water, Glycerin, Poloxamer 407, Flavor, Sodium Benzoate, Sucralose

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

    WITH
    50% MORE
    CPC‡

    TheraBreath™

    DENTIST FORMULATED

    PLAQUE CONTROL

    PRE-BRUSH

    ORAL RINSE

    HELPS FIGHT PLAQUE & GINGIVITIS FOR 24 HOURS*

    ANTI-BACTERIAL RINSE • CLEANS WHOLE MOUTH

    No Alcohol • No Dyes • Non Burning

    COOL MINT

    16 fl. oz.
    473 mL

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    THERABREATH PLAQUE CONTROL 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-259
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.015 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-259-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35604/25/2023
    Labeler - Church & Dwight Co., Inc. (001211952)
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