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

  • NDC Code(s): 64854-012-01, 64854-014-11, 64854-018-01, 64854-044-01
  • 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 16, 2022

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  • Toothpaste

    Active ingredients

    Sodium Fluoride 0.243%

    Purpose

    Anticavity

    Use

    aids in the prevention of dental cavities

    Warnings

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

    Warnings

    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 yearsInstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
    Children under 2 years of ageConsult a dentist or doctor.

    Other information

    • store at 15° - 30°C (59° - 86°F)
    • twist off cap and remove foil seal

    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

  • Tongue Spray

    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 olderspray 2-3 times on the back of the tongue and gently scape with cleaner

    children 6 - 12 years of age

    		supervise use

    children under 6 years     		do not use

    Other Information

    Store at 15°–30°C (59°–86°F)

    Inactive Ingredients

    Blue 1, Flavor (Peppermint Oil, Thymol and Eucalyptus Oil), PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Saccharin, Water, Zinc Gluconate

  • Mouth Rinse

    Active Ingredients


    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.

    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 oldervigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out
    Children 6 years to under 12 yearssupervise use
    Children under 6 yearsdo not use

    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

    Other Information

    • store at 15° - 30°C (59° - 86°F)

    • this rinse is not intended to replace brushing or flossing
  • WARNINGS

    Do not use products if seals are broken or missing.

  • Package Label

    Carton - Front

    Carton - Back

  • INGREDIENTS AND APPEARANCE
    BREATHRX WITH ZYTEX 
    cetylpyridinium chloride,sodium fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-044
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-044-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package09/18/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 237 mL
    Part 21 BOTTLE, PLASTIC 59 mL
    Part 31 TUBE 112 g
    Part 1 of 3
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    MINT (UNII: FV98Z8GITP)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    THYMOL (UNII: 3J50XA376E)  
    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 Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/21/2006
    Part 2 of 3
    BREATHRX WITH ZYTEX 
    cetylpyridinium chloride spray
    Product Information
    Item 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
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    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 Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/21/2006
    Part 3 of 3
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    MINT (UNII: FV98Z8GITP)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    WATER (UNII: 059QF0KO0R)  
    MICA (UNII: V8A1AW0880)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    Product Characteristics
    Colorblue (Blue with sparkles) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64854-018-01112 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart356,part35509/18/2014
    Labeler - Discus Dental, LLC (831726109)
    Registrant - Discus Dental, LLC (831726109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Discus Dental, LLC831726109manufacture(64854-044)
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