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BreathRx with Zytex by Discus Dental, LLC

Medically reviewed on June 18, 2018

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 with Zytex 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)

Do not use if seal is not intact.

Package Labels

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.

Anticavity

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%

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:64854-018-0236 TUBE in 1 PACKAGE
1112 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)
Establishment
NameAddressID/FEIOperations
Discus Dental, LLC831726109manufacture(64854-018)

 
Discus Dental, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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