Breathaway Mouth Rinse Fresh Mint

Drug Facts

Composition & Product

Active Ingredients

Cetylpyridinium (0.3394 g)

Inactive Ingredients

Acesulfame Potassium Anhydrous Citric Acid Ethyl Menthane Carboxamide Glycerin Myrrh Oil Poloxamer 407 Polyoxyl 40 Hydrogenated Castor Oil Polysorbate 20 Potassium Sorbate Sodium Benzoate Sodium Hydroxide Sorbitol Tea Tree Oil Water Xylitol Zinc Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-05-02 Until 2023-09-08

Medication Information

Warnings and Precautions

Warnings

Stop use and ask a dentist if symptoms persist or condition worsens after regular use.

Indications and Usage

Uses

helps prevent gingivitis
helps prevent plaque that leads to gingivitis

Dosage and Administration

Directions

adults and children 12 years of age and older: vigorously swish 20 mL (4 teaspoonfuls) between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
children 6 years to under 12 years of age: supervise use.
children under 6 years of age: do not use

Description

Active ingredient Cetylpyridinium chloride 0.07%

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

water, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil

Section 51945-4

Section 55105-1

Purpose

Antigingivitis/Antiplaque

Section 55106-9

Active ingredient

Cetylpyridinium chloride 0.07%

Structured Label Content

Indications and Usage (34067-9)

Uses

helps prevent gingivitis
helps prevent plaque that leads to gingivitis

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and older: vigorously swish 20 mL (4 teaspoonfuls) between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
children 6 years to under 12 years of age: supervise use.
children under 6 years of age: do not use

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a dentist if symptoms persist or condition worsens after regular use.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

water, sorbitol, glycerin, PEG-40 hydrogenated castor oil, polysorbate 20, sodium benzoate, flavor, potassium sorbate, citric acid, sodium hydroxide, poloxamer 407, xylitol, zinc citrate, potassium acesulfame, melaleuca alternifolia (tea tree) leaf oil, ethyl menthane carboxamide, commiphora myrrha oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antigingivitis/Antiplaque

Section 55106-9 (55106-9)

Active ingredient

Cetylpyridinium chloride 0.07%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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