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%

Packaging Labels (Bottle Front and Back 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: 64854-014-07	237 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)