Label: BREATHRX WITH ZYTEX- 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 December 16, 2022

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  • KEEP OUT OF REACH OF CHILDREN

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

  • OTHER SAFETY INFORMATION

    Other Information

    • Store at controlled room temperature 15 o - 30 oC (59 o - 86 oF)
  • 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.

  • INDICATIONS & USAGE

    Use:

    • helps prevent plaque that leads to gingivitis
    • helps fight odor-causing bacteria
  • PURPOSE

    Antibacterial, antiplaque, antigingivitis

  • 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
  • DOSAGE & ADMINISTRATION

    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
  • Active Ingredients

    Cetylpyridinium chloride 0.075%

  • Package Labels (Bottle Front and Back Labels)

    Front Label

    Front Label

    Back Label

    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
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    THYMOL (UNII: 3J50XA376E)  
    MINT (UNII: FV98Z8GITP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (Light blue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-014-0659 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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