FDA.reportPublic FDA data

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 ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8oz. front label8oz. front label

8 oz. - back label8 oz. - back label

16 oz. front label16 oz. front label

16 oz. back label16 oz. back label

33 oz. - front label33 oz. - front label

33 oz. back label33 oz. back label

1 gal - front label1 gal - front label

1 gal. - back label1 gal. - back label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64854-01464854-014-11, 64854-014-12, 64854-014-13, 64854-014-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
MINTFV98Z8GITPIACT
THYMOL3J50XA376EIACT
EUCALYPTUS OIL2R04ONI662IACT
SORBITOL506T60A25RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLOXAMER 407TUF2IVW3M2IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
XYLITOLVCQ006KQ1EIACT

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
0f1506e8-986c-7c4c-e063-6394a90a2b317bd694da-07bd-38e4-e053-2991aa0a6c562024-01-16WarningsExact identifier
spl set id: 7bd694da-07bd-38e4-e053-2991aa0a6c56

Reported adverse events (FAERS/openFDA)#

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