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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 yearsInstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
Children under 2 years of ageConsult 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 olderspray 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 oldervigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out
Children 6 years to under 12 yearssupervise use
Children under 6 yearsdo 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-044
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64854-044-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package09/18/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 237 mL
Part 21 BOTTLE, PLASTIC 59 mL
Part 31 TUBE 112 g
Part 1 of 3
BREATHRX WITH ZYTEX 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:64854-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (Light Blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64854-014-11237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/21/2006
Part 2 of 3
BREATHRX WITH ZYTEX 
cetylpyridinium chloride spray
Product Information
Item Code (Source)NDC:64854-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.85 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (Light Blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64854-012-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/21/2006
Part 3 of 3
BREATHRX WITH ZYTEX 
sodium fluoride paste, dentifrice
Product Information
Item Code (Source)NDC:64854-018
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (Blue with sparkles) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64854-018-01112 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/21/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart356,part35509/18/2014
Labeler - Discus Dental, LLC (831726109)
Registrant - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIBusiness Operations
Discus Dental, LLC831726109manufacture(64854-044)

Revised: 12/2021
Document Id: d3ae542c-7f06-9e68-e053-2a95a90acb09
Set id: 7c724825-a037-06aa-e053-2991aa0a8498
Version: 13
Effective Time: 20211221
 
Discus Dental, LLC