Label: THERABREATH HEALTHY GUMS- cetylpyridinium chloride rinse

  • NDC Code(s): 10237-258-01, 10237-258-03, 10237-258-16, 10237-258-20
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Cetylpyridinium Chloride 0.05%

  • 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, Sucralose

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE

    SAVE!
    VALUE
    SIZE

    TheraBreath™

    DENTIST FORMULATED

    HEALTHY GUMS

    ORAL RINSE

    HELPS FIGHT GINGIVITIS FOR 24 HOURS*

    HELPS REDUCE PLAQUE THAT LEADS TO GUM DISEASE

    Reduces Occurrence of Bleeding Gums • Freshens Breath
    No Alcohol • No Dyes • Non Burning

    CLEAN MINT

    33.8 fl. oz.
    1 liter

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    THERABREATH HEALTHY GUMS 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-258
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.01 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:10237-258-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    2NDC:10237-258-0388.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    3NDC:10237-258-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/13/2023
    4NDC:10237-258-2020 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02202/13/2023
    Labeler - Church & Dwight Co., Inc. (001211952)
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