Label: BREATHRX WITH ZYTEX- cetylpyridinium chloride spray

  • NDC Code(s): 64854-012-01, 64854-012-03
  • 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 0.085%

  • Purpose

    Antibacterial

  • Use

    Helps fight odor-causing bacteria

  • Warnings

    Do not use if seal is broken.

  • Warnings

    Keep out of reach of children under 6 years of age. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. If spray gets into eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.

  • Directions

    Shake before use

    adults and children 12 years of age and older

    spray 2-3 times on the back of the tongue and gently scape with cleaner
    children 6 - 12 years of agesupervise use
    children under 6 yearsdo not use

  • Other information

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

  • Inactive Ingredients

    Inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    Front Label

    Back Label

    Package label

  • INGREDIENTS AND APPEARANCE
    BREATHRX WITH ZYTEX 
    cetylpyridinium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.85 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorblue (Light blue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-012-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
    2NDC:64854-012-031 in 1 PACKAGE09/01/2014
    2NDC:64854-012-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    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(64854-012)
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