BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse 
Discus Dental, LLC

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.

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BreathRx Anti-bacterial Mouth Rinse

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

Other Information

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

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.

Use:

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

Antibacterial, antiplaque, antigingivitis

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

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 Bottle Labeling

Front Label 

Front label

Back Label

Back label

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 CHLORIDE.825 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:64854-014-0429 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/200612/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/21/200612/01/2017
Labeler - Discus Dental, LLC (831726109)
Registrant - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIBusiness Operations
Discus Dental, LLC831726109manufacture(64854-014)

Revised: 12/2017
Document Id: e70f6c22-078c-4d01-b4b0-f2c9d07ab7f1
Set id: 5c008e3d-f512-4cb5-b476-0fc44849f0ed
Version: 2
Effective Time: 20171213
 
Discus Dental, LLC