BREATHRX WITH ZYTEX- sodium fluoride paste, dentifrice 
Discus Dental, LLC

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BreathRx with Zytex Whitening Toothpaste

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

Other Information

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

Do not use if seal is not intact.

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%

Tube Label

Tube Label

Tube 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) SODIUM FLUORIDE2.43 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
1NDC:64854-018-0215 g in 1 TUBE; Type 0: Not a Combination Product11/21/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02111/21/200512/31/2023
Labeler - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIBusiness Operations
Discus Dental, LLC831726109manufacture(64854-018)

Revised: 1/2024
 
Discus Dental, LLC