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

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

Other Information

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:

Antibacterial, antiplaque, antigingivitis

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

Directions:

Active Ingredients

Cetylpyridinium chloride 0.075%

Package Labels (Bottle Front and Back Labels)

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 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)

Revised: 12/2022
Document Id: eff87255-e4b4-09e1-e053-2a95a90a4531
Set id: 9ea86566-ef66-4923-b644-66f59039de24
Version: 7
Effective Time: 20221216
 
Discus Dental, LLC