BreathAway Mouth Rinse Cinnamon

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.3394g in 473mL
Labeler: Melaleuca, Inc.
NDC Code: 54473-208

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

BreathAway Mouth Rinse Cinnamon Content of Label

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis/Antiplaque

Use

  • helps prevent gingivitis
  • helps prevent plaque that leads to gingivitis

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

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.

Directions

  • adults and children 12years 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 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

BREATHAWAY  MOUTH RINSE CINNAMON
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-208
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.3394 g  in 473 mL
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:54473-208-16473 mL in 1 BOTTLE
2NDC:54473-208-08237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/02/2011
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIOperations
Melaleuca, Inc.139760102manufacture

Revised: 04/2011
 
Melaleuca, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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