BreathRx with Zytex

Manufacturer
Discus Dental, LLC
Effective date
2022-12-16
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 21:44:19

Label at a glance#

ProductBreathRx with Zytex
Active ingredientSODIUM FLUORIDE, CETYLPYRIDINIUM CHLORIDE
Label structure3 sections

Label contents#

Full prescribing information#

Mouth Rinse

COMPONENTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.075%

Purpose

OTC - PURPOSE SECTION

Antibacterial, antiplaque, antigingivitis

Use

INDICATIONS & USAGE SECTION

Helps prevent plaque that leads to gingivitis
Helps fight odor-causing bacteria

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Do not use if seal is broken.

Warnings

WARNINGS SECTION

Stop use an ask a dentist if: gingivitis, bleeding, or redness persists for more than 2 weeks; you have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not swallow rinse. Adults and children 12 years of age and older: vigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out. Children 6 years to under 12 years: supervise use. Children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°–30°C (59°–86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Blue 1, Citric acid, Cocamidopropyl Betaine, Flavor (Mint, Thymol and Eucalyptus Oil), PEG-40 Hydrogenated Castor oil, Poloxamer 407, Propylene Glycol, Sodium Saccharin, Sorbitol, Water, Xylitol, Zinc gluconate.

Toothpaste

COMPONENTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

Purpose

OTC - PURPOSE SECTION

Anticavity

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

Other Information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Warning

WARNINGS SECTION

Do not use if seal is not intact.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mouth Rinse - Front LabelMouth Rinse - Front Label

Mouth Rinse - Back LabelMouth Rinse - Back Label

Toothpaste - LabelToothpaste - Label

Kit - LabelKit - Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64854-03264854-032-01
64854-01864854-018-04
64854-01464854-014-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0f16482a-3c07-09da-e063-6294a90a7e967cb55fd6-f286-e3b1-e053-2991aa0a91e12024-01-16WarningsExact identifier
spl set id: 7cb55fd6-f286-e3b1-e053-2991aa0a91e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.