BREATHRX WITH ZYTEX- cetylpyridinium chloride rinse

BreathRx with Zytex by

Drug Labeling and Warnings

BreathRx with Zytex by is a Otc medication manufactured, distributed, or labeled by Discus Dental, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

Other Information

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

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.

INDICATIONS & USAGE

Use:

• helps prevent plaque that leads to gingivitis
• helps fight odor-causing bacteria

PURPOSE

Antibacterial, antiplaque, antigingivitis

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

DOSAGE & ADMINISTRATION

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%

Package Labels

Front label

Back label

INGREDIENTS AND APPEARANCE

BREATHRX WITH ZYTEX 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64854-014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
THYMOL (UNII: 3J50XA376E)
MINT (UNII: FV98Z8GITP)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (Light blue)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64854-014-03	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/21/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/21/2006

Labeler - Discus Dental, LLC (831726109)

Registrant - Discus Dental, LLC (831726109)

Establishment
Name	Address	ID/FEI	Business Operations
Discus Dental, LLC		831726109	manufacture(64854-014)