BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse 
Discus Dental, LLC

----------

BreathRx Anti-bacterial Mouth Rinse

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

Other Information

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

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 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:64854-014-02976 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 DrugM02207/21/200612/31/2023
Labeler - Discus Dental, LLC (831726109)
Registrant - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIBusiness Operations
Discus Dental, LLC831726109manufacture(64854-014)

Revised: 1/2024
Document Id: 0f15afc5-fa73-abbc-e063-6294a90a84d6
Set id: c5175592-522f-4b7b-a7cb-07526abdd6c0
Version: 8
Effective Time: 20240116
 
Discus Dental, LLC