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BreathRx with Zytex by Discus Dental, LLC

Dosage form: spray
Ingredients: CETYLPYRIDINIUM CHLORIDE .85mg in 1mL
Labeler: Discus Dental, LLC
NDC Code: 64854-012

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 Antibacterial Tongue Spray

Warning:

Keep out of reach of children under 6 years of age

Package Labels

Inactive Ingredients:

Blue 1, Flavor (Peppermint Oil, Thymol and Eucalyptus Oil), PEG 8 Dimethicone, Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Saccharin, Water, Zinc Gluconate

Use:

Helps fight odor-causing bacteria.´╗┐

Purpose:

Antibacterial

Warning:

Do not use if seal is broken. If more than twice teh 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 older: spray 2-3 times on the back of the tongue and gently scape with cleaner.
  • Children 6 years to under 12 years: supervise use.
  • Children under 6 years: do not use.

´╗┐Active Ingredients

Cetylpyridinium chloride 0.090%

Other Information:

Store at 15o - 30oC (59o - 86oF)

BREATHRX WITH ZYTEX 
cetylpyridinium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE.85 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:64854-012-0159 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(64854-012)

Revised: 04/2015
 
Discus Dental, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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