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]

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

Other Information

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

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.

PURPOSE

Anticavity

INDICATIONS & USAGE

Anticavity

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

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)	FLUORIDE ION	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
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: 64854-018-02	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)

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