BREATHRX WITH ZYTEX- sodium fluoride paste, dentifrice 
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.

----------

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%

Packaging labeling

Tube Label

Tube Label

Box Label

Box Label

BREATHRX WITH ZYTEX 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64854-018
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION243 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
MINT (UNII: FV98Z8GITP)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
Product Characteristics
Colorblue (BLUE WITH SPARKLES) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10-7502004810-31 in 1 PACKAGE11/21/200512/01/2017
1NDC:64854-018-03112 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/21/200512/01/2017
Labeler - Discus Dental, LLC (831726109)
Registrant - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIBusiness Operations
Discus Dental, LLC831726109manufacture(64854-018)

Revised: 12/2017
 
Discus Dental, LLC