E-ZEN GARGLE - cetylpyridinium chloride liquid 
JN Pharm

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Drug Facts

Cetylpyridinium chloride

Xylitol, Glucosyl Stevioside, Sodium Saccharin, Disodium EDTA, Glycerin, Blue No.1, Sodium citrate, Ethanol, Methylparaben, Polyoxyethylene Hydrogenated Castor Oil, Menthol, Mentha Oil, Purified water


Plaque removal. Mouth cleanliness, Halitosis removal

keep out or reach of the children


-Before going to bed or after eating, wash your mouth out with 12ML of gargling liquid.-Gargle with E-zen frequently when your mouth doesn't feel fresh.

Never let children under the age of 6 use the product.Keep out of reach of children.Children under the age of 7 must use the product under the guidance of an adult.In case of accidental swallowing, see a doctor.

dental use only


package label
E-ZEN GARGLE 
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62040-2001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.005 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62040-2001-112 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/08/2014
Labeler - JN Pharm (689048618)
Registrant - JN Pharm (689048618)
Establishment
NameAddressID/FEIBusiness Operations
JN Pharm689048618manufacture(62040-2001)

Revised: 2/2014
Document Id: a617a4e0-2f51-4da9-8990-ba6bbd7b0159
Set id: 9540d7ac-8dc0-4764-b42e-e3f4d33a07c6
Version: 1
Effective Time: 20140208
 
JN Pharm