BREATHRX WITH ZYTEX- cetylpyridinium chloride spray 
Discus Dental, LLC

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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

Inactive ingredients

Front Label

Back Label

Package label

BREATHRX WITH ZYTEX 
cetylpyridinium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.85 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Colorblue (Light blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64854-012-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
2NDC:64854-012-031 in 1 PACKAGE09/01/2014
2NDC:64854-012-0159 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
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(64854-012)

Revised: 1/2024
Document Id: 0f14a29a-6671-1640-e063-6294a90a539d
Set id: 7be46858-d6eb-45e3-a6c5-dbe394db04da
Version: 15
Effective Time: 20240116
 
Discus Dental, LLC