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

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Active ingredient

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. Supervise children as necessary until capable of using without supervision.

adults and children 2 years of age and olderbrush 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.

Do not use if seal is broken.

Inactive ingredients

Inactive ingredients

Tube - 4oz - Label

Package - 4oz - Label

Tube - 0.5oz - 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
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
MICA (UNII: V8A1AW0880)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITOL (UNII: 506T60A25R)  
THYMOL (UNII: 3J50XA376E)  
MINT (UNII: FV98Z8GITP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
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 Product11/21/2005
2NDC:64854-018-051 in 1 PACKAGE11/21/2005
2NDC:64854-018-01112 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:64854-018-0415 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)
Registrant - Discus Dental, LLC (831726109)
Establishment
NameAddressID/FEIBusiness Operations
Discus Dental, LLC831726109manufacture(64854-018)

Revised: 1/2024
 
Discus Dental, LLC