Label: BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse

  • NDC Code(s): 64854-014-11, 64854-014-12, 64854-014-13, 64854-014-14
  • Packager: Discus Dental, LLC
  • 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 December 16, 2022

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  • Active Ingredient

    Cetylpyridinium chloride 0.075%

  • Purpose

    Antibacterial, antiplaque, antigingivitis

  • Use

    Helps prevent plaque that leads to gingivitis
    Helps fight odor-causing bacteria

  • Warnings

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Do not use if seal is broken

  • Warnings

    Keep out of reach of children under 6 years of age.

  • Directions

    Do not swallow rinse. Adults and children 12 years of age and older: vigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out. Children 6 years to under 12 years: supervise use. Children under 6 years of age: do not use

  • Other information

    Store at controlled room temperature 15°–30°C (59°–86°F)

  • Inactive Ingredients

    Blue 1, Citric acid, Cocamidopropyl Betaine, Flavor (Mint, Thymol and Eucalyptus Oil), PEG-40 Hydrogenated Castor oil, Poloxamer 407, Propylene Glycol, Sodium Saccharin, Sorbitol, Water, Xylitol, Zinc gluconate

  • PRINCIPAL DISPLAY PANEL

    8oz. front label

    8 oz. - back label

    16 oz. front label

    16 oz. back label

    33 oz. - front label

    33 oz. back label

    1 gal - front label

    1 gal. - back label

  • INGREDIENTS AND APPEARANCE
    BREATHRX WITH ZYTEX 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MINT (UNII: FV98Z8GITP)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorblue (Light blue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-014-11237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
    2NDC:64854-014-12473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
    3NDC:64854-014-13976 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
    4NDC:64854-014-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/21/2006
    Labeler - Discus Dental, LLC (831726109)
    Registrant - Discus Dental, LLC (831726109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Discus Dental, LLC831726109manufacture(64854-014)
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