Label: THERABREATH DEEP CLEAN FRESH MINT- cetylpyridinium chloride rinse

  • NDC Code(s): 10237-261-03, 10237-261-16
  • 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

    Cetylpyridinium Chloride 0.1%

  • 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

    Flavor, Glycerin, Poloxamer 407, Sucralose, Water

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    ALCOHOL
    FREE

    ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

    TheraBreath™

    DENTIST FORMULATED

    DEEP CLEAN

    ORAL RINSE

    KILLS 99.9% OF GERMS
    THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS*

    ANTISEPTIC

    No Alcohol • No Dyes • Non Burning

    FRESH MINT

    16 fl.oz.
    473 mL

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    THERABREATH DEEP CLEAN FRESH MINT 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-261
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE20 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-261-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2024
    2NDC:10237-261-0388.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02202/15/2024
    Labeler - Church & Dwight Co., Inc. (001211952)
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