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BreathAway Mouth Rinse Fresh Mint

Medically reviewed by Drugs.com. Last updated on Mar 19, 2020.

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.3394g in 473mL
Labeler: Melaleuca, Inc.
NDC Code: 54473-294

BreathAway Mouth Rinse Fresh Mint

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis/Antiplaque

Uses

  • 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 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 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 FRESH MINT
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-294
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:54473-294-16473 mL in 1 BOTTLE
2NDC:54473-294-08237 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.079711683manufacture(54473-294)

 
Melaleuca, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.