AURORA ALCOHOL FREE CLEAN MINT- cetylpyridinium chloride mouthwash 
Apollo Health and Beauty Care

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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DRUG FACTS

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antiplaque/Antigingivitis

Uses

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

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

Image of the label

AURORA ALCOHOL FREE CLEAN MINT 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-553
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-553-501000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/14/2016
Labeler - Apollo Health and Beauty Care (201901209)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(63148-553)

Revised: 6/2016
Document Id: 256504f1-abbb-4e05-9886-e3c06eea6af1
Set id: 095b9ec1-94f6-4933-979c-7370ac2ad7c0
Version: 1
Effective Time: 20160615
 
Apollo Health and Beauty Care