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BreathRx with Zytex by Discus Dental, LLC

Medically reviewed on Apr 30, 2018

Dosage form: rinse
Ingredients: CETYLPYRIDINIUM CHLORIDE .825mg in 1mL
Labeler: Discus Dental, LLC
NDC Code: 64854-014

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.

BreathRx Anti-bacterial Mouth Rinse

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

Other Information

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

Package Labels

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%

BREATHRX WITH ZYTEX 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-014
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE.825 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 407 
WATER 
ANHYDROUS CITRIC ACID 
ZINC GLUCONATE 
XYLITOL 
SACCHARIN SODIUM 
SORBITOL 
COCAMIDOPROPYL BETAINE 
PROPYLENE GLYCOL 
THYMOL 
MINT 
EUCALYPTUS OIL 
PEG-40 CASTOR OIL 
FD&C BLUE NO. 1 
Product Characteristics
Colorblue (Light blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64854-014-02976 mL in 1 BOTTLE, PLASTIC
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/FEIOperations
Discus Dental, LLC831726109manufacture(64854-014)

 
Discus Dental, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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