BreathAway Mouth Rinse Fresh Mint

BREATHAWAY MOUTH RINSE FRESH MINT- 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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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54473-294
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.3394 g in 473 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54473-294-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018
2	NDC:54473-294-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018	09/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/02/2011

Labeler - Melaleuca, Inc. (139760102)

Name	Address	ID/FEI	Business Operations
Establishment
Melaleuca, Inc.		079711683	manufacture(54473-294)