BreathAway Mouth Rinse Cinnamon Content of Label

BreathAway Mouth Rinse Cinnamon Content of Label

Drug Labeling and Warnings

Drug Details

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BREATHAWAY MOUTH RINSE CINNAMON- cetylpyridinium chloride mouthwash 
Melaleuca, Inc.

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.

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BreathAway Mouth Rinse Cinnamon Content of Label

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis/Antiplaque

Use

  • helps prevent gingivitis
  • helps prevent plaques 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

image of label

image of label
BREATHAWAY  MOUTH RINSE CINNAMON
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54473-293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.3394 g  in 473 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
GLYCERIN (UNII: PDC6A3C0OX)  
MYRRH OIL (UNII: H74221J5J4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITOL (UNII: 506T60A25R)  
TEA TREE OIL (UNII: VIF565UC2G)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC CITRATE (UNII: K72I3DEX9B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54473-293-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
2NDC: 54473-293-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/02/2011
Labeler - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-293)

Revised: 2/2018
 
Melaleuca, Inc.


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