FDA Label for Breathaway Mouth Rinse Fresh Mint
View Indications, Usage & Precautions
Breathaway Mouth Rinse Fresh Mint Product Label
The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient
Cetylpyridinium chloride 0.07%
Otc - Purpose
Purpose
Antigingivitis/Antiplaque
Indications & Usage
Uses
- helps prevent gingivitis
- helps prevent plaque that leads to gingivitis
Warnings
Warnings
Stop use and ask a dentist if symptoms persist or condition worsens after regular use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & 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
Inactive Ingredient
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
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