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BreathRx with Zytex by Discus Dental, LLC

Medically reviewed by Drugs.com. Last updated on Nov 28, 2018.

Dosage form: spray
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.85mg 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.

Active Ingredient

Cetylpyridinium chloride 0.085%

Purpose

Antibacterial

Use

Helps fight odor-causing bacteria

Warnings

Do not use if seal is broken.

Warnings

Keep out of reach of children under 6 years of age. If more than twice the 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 - 12 years of agesupervise use
children under 6 yearsdo not use

Other information

Store at controlled room temperature 15°–30°C (59°–86°F)

Inactive Ingredients

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 CHLORIDE0.85 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
PEPPERMINT OIL (PEPPERMINT)  
THYMOL 
EUCALYPTUS OIL 
PEG-12 DIMETHICONE 
SACCHARIN SODIUM (SACCHARIN)  
WATER 
ZINC GLUCONATE 
PEG-40 CASTOR OIL 
PROPYLENE GLYCOL 
Product Characteristics
Colorblue (Light blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64854-012-0159 mL in 1 BOTTLE, PLASTIC
2NDC:64854-012-031 BOTTLE, PLASTIC in 1 PACKAGE
2NDC: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)

 
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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