Label: THERABREATH HEALTHY GUMS ORAL RINSE- cetylpyridinium chloride rinse

  • Category: HUMAN OTC DRUG LABEL

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 1, 2022

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  • Active Ingredient

    Cetylpyridinium chloride 0.05%

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

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

  • Warnings

    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.

  • Warnings

    Stop Use and Ask a Doctor 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 or symptoms of periodontitis, a serious form of gum disease.

  • Directions

    Adults and Children 12 years and older

    Vigorously 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 under12 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

  • TheraBreath Healthy Gums Oral Rinse

    label

    72551-247-05

  • PRINCIPAL DISPLAY PANEL

    72551-247-01

    Label

  • PRINCIPAL DISPLAY PANEL

    72551-247-04

    label

  • INGREDIENTS AND APPEARANCE
    THERABREATH HEALTHY GUMS ORAL RINSE 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-247
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.0005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72551-247-01473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2020
    2NDC:72551-247-0433.8 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2020
    3NDC:72551-247-0588.7 g in 1 POUCH; Type 0: Not a Combination Product12/01/2020
    4NDC:72551-247-06958.21 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    5NDC:72551-247-07283.5 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    6NDC:72551-247-0885.05 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    7NDC:72551-247-097.09 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/202001/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2020
    Labeler - Dr. Harold Katz, LLC (965507767)
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