AURORA ALCOHOL FREE CLEAN MINT- cetylpyridinium chloride mouthwash

Aurora Alcohol Free Clean Mint by

Drug Labeling and Warnings

Aurora Alcohol Free Clean Mint by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antiplaque/Antigingivitis

Uses

• Helps reduce and prevent plaque and gingivitis.
• Helps control bacteria plaque that contributes to the development of gingivitis and bleeding gums.

Warnings

Ask a dentist if symptoms persist or condition worsens after regular use.

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

• Use after your normal brushing and flossing routein; rinse toothpaste from mouth prior to use.
• ​Adults and children 6 years of age and older:​ Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day.
• do not swallow.
• children 6 years to under 12 years of age: supervise use.
• ​children under 6 years of age: do not use.

Other information

Store at room temperature.

Inactive ingredients

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

Questions or comments?

1-866-695-3030

Label Copy

INGREDIENTS AND APPEARANCE

AURORA ALCOHOL FREE CLEAN MINT 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-553
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-553-50	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/14/2016

Labeler - Apollo Health and Beauty Care (201901209)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(63148-553)