Skip to Content

← See all BreathRx with Zytex brands

BreathRx with Zytex by Discus Dental, LLC

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 243mg in 1g
Labeler: Discus Dental, LLC
NDC Code: 64854-018

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.

BreathRx Whitening Toothpaste

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

Other Information

  • Store at controlled room temperature 15o - 30oC (59o - 86oF)

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.

Use: Aids in the prevention of dental cavities

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.

Twist off cap and remove foil seal. Do not use if seal is not intact.

Active Ingredients

Sodium Fluoride 0.243%

Tube Package Labeling

Tube Label

BREATHRX WITH ZYTEX 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-018
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION243 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
CARBOXYMETHYLCELLULOSE 
MINT 
THYMOL 
EUCALYPTUS OIL 
GLYCERIN 
MICA 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 600 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SODIUM METHYL COCOYL TAURATE 
SACCHARIN SODIUM 
SORBITOL 
POTASSIUM PYROPHOSPHATE 
SODIUM PYROPHOSPHATE 
WATER 
XANTHAN GUM 
XYLITOL 
ZINC GLUCONATE 
Product Characteristics
Colorblue (BLUE WITH SPARKLES) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64854-018-01112 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/21/2005
Labeler - Discus Dental, LLC (831726109)
Registrant - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIOperations
Discus Dental, LLC831726109manufacture(64854-018)

Revised: 12/2017
 
Discus Dental, LLC

← See all BreathRx with Zytex brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide