BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse 
Discus Dental, LLC

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Active Ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antibacterial, antiplaque, antigingivitis

Use

Helps prevent plaque that leads to gingivitis
Helps fight odor-causing bacteria

Warnings

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

Warnings

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

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

Other information

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

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

8oz. front label

8 oz. - back label

16 oz. front label

16 oz. back label

33 oz. - front label

33 oz. back label

1 gal - front label

1 gal. - 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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MINT (UNII: FV98Z8GITP)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorblue (Light blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64854-014-11237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
2NDC:64854-014-12473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
3NDC:64854-014-13976 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2006
4NDC:64854-014-143785 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
 
Discus Dental, LLC