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, SODIUM FLUORIDE
Label structure5 sections

Label contents#

Full prescribing information#

Toothpaste

COMPONENTS

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

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 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 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

STORAGE AND HANDLING SECTION

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

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

Tongue Spray

COMPONENTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.085%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

Helps fight odor-causing bacteria

Warnings

WARNINGS SECTION

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. If more than twice the recommended amount for tongue spraying is accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not spray into the eyes. If spray gets into eyes, hold eyelids apart and flush the eye continuously with running water for at least 15 minutes.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake before use

adults and children 12 years of age and olderspray 2-3 times on the back of the tongue and gently scape with cleaner

children 6 - 12 years of age

supervise use

children under 6 years
do not use

Other Information

STORAGE AND HANDLING SECTION

Store at 15°–30°C (59°–86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Blue 1, Flavor (Peppermint Oil, Thymol and Eucalyptus Oil), PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Propylene Glycol, Sodium Saccharin, Water, Zinc Gluconate

Mouth Rinse

COMPONENTS

Active Ingredients

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.

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 oldervigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out
Children 6 years to under 12 yearssupervise use
Children under 6 yearsdo not use

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

Other Information

STORAGE AND HANDLING SECTION

  • store at 15° - 30°C (59° - 86°F)
  • this rinse is not intended to replace brushing or flossing

WARNINGS SECTION

Do not use products if seals are broken or missing.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton - FrontCarton - Front

Carton - BackCarton - Back

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Ingredients#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0f169ba9-f41d-4ae8-e063-6294a90a2e317c724825-a037-06aa-e053-2991aa0a84982024-01-16WarningsExact identifier
spl set id: 7c724825-a037-06aa-e053-2991aa0a8498

Reported adverse events (FAERS/openFDA)#

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