BREATHRX WITH ZYTEX- sodium fluoride paste, dentifrice

BreathRx with Zytex by

Drug Labeling and Warnings

BreathRx with Zytex by is a Otc medication manufactured, distributed, or labeled by Discus Dental, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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.

Other information

• store at 15° - 30°C (59° - 86°F)
• twist off cap and remove foil seal.

WARNINGS

Do not use if seal is broken.

Inactive ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BREATHRX WITH ZYTEX 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64854-018
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (BLUE WITH SPARKLES)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64854-018-01	112 g in 1 TUBE; Type 0: Not a Combination Product	11/21/2005
2	NDC: 64854-018-05	1 in 1 PACKAGE	11/21/2005
2	NDC: 64854-018-01	112 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 64854-018-04	15 g in 1 TUBE; Type 0: Not a Combination Product	11/21/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/21/2005

Labeler - Discus Dental, LLC (831726109)

Registrant - Discus Dental, LLC (831726109)

Establishment
Name	Address	ID/FEI	Business Operations
Discus Dental, LLC		831726109	manufacture(64854-018)