Label: BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride kit

  • NDC Code(s): 64854-014-10, 64854-018-04, 64854-032-01
  • 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 21, 2021

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  • Mouth Rinse

    Active Ingredient

    Cetylpyridinium chloride 0.075%

    Purpose

    Antibacterial, antiplaque, antigingivitis

    Use

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

    Warnings

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

    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

    Stop use an ask a dentist 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 be signs or symptoms of periodontitis, a serious form of gum disease.

    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.

  • Toothpaste

    Active Ingredients

    Sodium Fluoride 0.243%

    Purpose

    Anticavity

    Warning

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

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

    Directions

    Do not swallow rinse. Supervise children as necessary until capable of using without supervision.
    Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 years to 6 years: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 2 years of age: Consult a dentist or doctor.

    Other Information

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

    Inactive Ingredients

    Blue 1,Cellulose Gum, Flavor (Mint, Thymol and Eucalyptus Oil), Glycerin, Mica & Titanium Dioxide, PEG-12, Silica, Sodium Lauryl Sulfate, Sodium Methyl Cocoyl Taurate, Sodium Saccharin, Sorbitol, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Water, Xanthan Gum, Xylitol, Zinc gluconate

    Warning

    Do not use if seal is not intact.

  • PRINCIPAL DISPLAY PANEL

    Mouth Rinse - Front Label

    Mouth Rinse - Back Label

    Toothpaste - Label

    Kit - Label

  • INGREDIENTS AND APPEARANCE
    BREATHRX WITH ZYTEX 
    cetylpyridinium chloride,sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-032
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-032-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package04/19/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 15 g
    Part 21 BOTTLE, PLASTIC 59 mL
    Part 1 of 2
    BREATHRX WITH ZYTEX 
    sodium fluoride paste, dentifrice
    Product Information
    Item Code (Source)NDC:64854-018
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MICA (UNII: V8A1AW0880)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    MINT (UNII: FV98Z8GITP)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Product Characteristics
    Colorblue (BLUE WITH SPARKLES) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-018-0415 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/21/2005
    Part 2 of 2
    BREATHRX WITH ZYTEX 
    cetylpyridinium chloride rinse
    Product Information
    Item 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)  
    MINT (UNII: FV98Z8GITP)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblue (Light Blue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-014-1059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/21/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart356,part35504/19/2017
    Labeler - Discus Dental, LLC (831726109)
    Registrant - Discus Dental, LLC (831726109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Discus Dental, LLC831726109manufacture(64854-032)