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]

Toothpaste

Active ingredients

Sodium Fluoride 0.243%

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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

Warnings

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 15° - 30°C (59° - 86°F)
• twist off cap and remove foil seal

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

Tongue Spray

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 age: supervise use
• children under 6 years: do not use

Other Information

Store at 15°–30°C (59°–86°F)

Inactive Ingredients

Blue 1, Flavor (Peppermint Oil, Thymol and Eucalyptus Oil), PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Saccharin, Water, Zinc Gluconate

Mouth Rinse

Active Ingredients

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.

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: do not use

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

Other Information

• store at 15° - 30°C (59° - 86°F)

• this rinse is not intended to replace brushing or flossing

WARNINGS

Do not use products if seals are broken or missing.

Package Label

INGREDIENTS AND APPEARANCE

BREATHRX WITH ZYTEX 
cetylpyridinium chloride,sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64854-044

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64854-044-01	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	09/18/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	112 g
Part 2	1 BOTTLE, PLASTIC	237 mL
Part 3	1 BOTTLE, PLASTIC	59 mL

Part 1 of 3

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

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: 64854-018-01	112 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

Part 2 of 3

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

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: 64854-014-11	237 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 3 of 3

BREATHRX WITH ZYTEX 
cetylpyridinium chloride spray

Product Information
Item Code (Source)	NDC: 64854-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.85 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
WATER (UNII: 059QF0KO0R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
THYMOL (UNII: 3J50XA376E)
EUCALYPTUS OIL (UNII: 2R04ONI662)

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: 64854-012-01	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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356,part355	09/18/2014

Labeler - Discus Dental, LLC (831726109)

Registrant - Discus Dental, LLC (831726109)

Establishment
Name	Address	ID/FEI	Business Operations
Discus Dental, LLC		831726109	manufacture(64854-044)