Label: BREATHAWAY MOUTH RINSE FRESH MINT- cetylpyridinium chloride mouthwash

  • NDC Code(s): 54473-294-08, 54473-294-16
  • Packager: Melaleuca, 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 January 30, 2023

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  • ACTIVE INGREDIENT

    Active ingredient
    Cetylpyridinium chloride 0.07%

  • PURPOSE

    Purpose
    Antigingivitis/Antiplaque

  • INDICATIONS & USAGE

    Uses

    • helps prevent gingivitis
    • helps prevent plaque that leads to gingivitis
  • WARNINGS

    Warnings
    Stop use and ask a dentist if symptoms persist or condition worsens after regular use.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older: vigorously swish 20 mL (4 teaspoonfuls) between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
    • children 6 years to under 12 years of age: supervise use.
    • children under 6 years of age: do not use
  • INACTIVE INGREDIENT

    Inactive ingredients
    water, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil

  • PRINCIPAL DISPLAY PANEL

    image of label
  • PRINCIPAL DISPLAY PANEL

    image of label
  • INGREDIENTS AND APPEARANCE
    BREATHAWAY  MOUTH RINSE FRESH MINT
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-294
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.3394 g  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MYRRH OIL (UNII: H74221J5J4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-294-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    2NDC:54473-294-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/201809/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/02/2011
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-294)
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