BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride kit

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]

Mouth Rinse

Active Ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antibacterial, antiplaque, antigingivitis

Use

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

Warnings

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

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

Stop use an ask a dentist if: gingivitis, bleeding, or redness persists for more than 2 weeks; you have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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.

Toothpaste

Active Ingredients

Sodium Fluoride 0.243%

Purpose

Anticavity

Warning

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Do not swallow rinse. Supervise children as necessary until capable of using without supervision.
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 years to 6 years: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 2 years of age: Consult a dentist or doctor.

Other Information

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

Inactive Ingredients

Blue 1,Cellulose Gum, Flavor (Mint, Thymol and Eucalyptus Oil), Glycerin, Mica & Titanium Dioxide, PEG-12, Silica, Sodium Lauryl Sulfate, Sodium Methyl Cocoyl Taurate, Sodium Saccharin, Sorbitol, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Water, Xanthan Gum, Xylitol, Zinc gluconate

Warning

Do not use if seal is not intact.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BREATHRX WITH ZYTEX 
cetylpyridinium chloride,sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64854-032

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64854-032-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	04/19/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	59 mL
Part 2	1 TUBE	15 g

Part 1 of 2

BREATHRX WITH ZYTEX 
cetylpyridinium chloride rinse

Product Information
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	0.75 mg  in 1 mL

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

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: 64854-014-10	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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

Part 2 of 2

BREATHRX WITH ZYTEX 
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC: 64854-018
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
MINT (UNII: FV98Z8GITP)
THYMOL (UNII: 3J50XA376E)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	blue (BLUE WITH SPARKLES)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64854-018-04	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/21/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356,part355	04/19/2017

Labeler - Discus Dental, LLC (831726109)

Registrant - Discus Dental, LLC (831726109)

Establishment
Name	Address	ID/FEI	Business Operations
Discus Dental, LLC		831726109	manufacture(64854-032)