BREATHRX WITH ZYTEX- cetylpyridinium chloride,sodium fluoride
Discus Dental, LLC

----------

Starter Kit

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

Do not use products if seals are broken or missing.

Package Label

Carton - Front

Carton - Back

BREATHRX WITH ZYTEX
cetylpyridinium chloride,sodium fluoride kit

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

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

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

Part 1 of 3

BREATHRX WITH ZYTEX
cetylpyridinium chloride rinse

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
EUCALYPTUS OIL (UNII: 2R04ONI662)
WATER (UNII: 059QF0KO0R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
THYMOL (UNII: 3J50XA376E)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64854-014-11	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	07/21/2006	12/31/2023

Part 2 of 3

BREATHRX WITH ZYTEX
cetylpyridinium chloride spray

Product Information
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64854-012-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	07/21/2006	12/31/2023

Part 3 of 3

BREATHRX WITH ZYTEX
sodium fluoride paste, dentifrice

Product Information
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
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)
MICA (UNII: V8A1AW0880)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
GLYCERIN (UNII: PDC6A3C0OX)
THYMOL (UNII: 3J50XA376E)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)

Product Characteristics
Color	blue (Blue with sparkles)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64854-018-01	112 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	11/21/2005	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	09/18/2014	12/31/2023

Labeler - Discus Dental, LLC (831726109)

Registrant - Discus Dental, LLC (831726109)

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

Revised: 1/2024

Document Id: 0f169ba9-f41d-4ae8-e063-6294a90a2e31

Set id: 7c724825-a037-06aa-e053-2991aa0a8498

Version: 15

Effective Time: 20240116

Discus Dental, LLC