E-ZEN GARGLE- cetylpyridinium chloride liquid

E-zen Gargle by

Drug Labeling and Warnings

E-zen Gargle by is a Otc medication manufactured, distributed, or labeled by JN Pharm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cetylpyridinium chloride

INACTIVE INGREDIENT

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

PURPOSE

Plaque removal. Mouth cleanliness, Halitosis removal

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

-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.

WARNINGS

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.

DOSAGE & ADMINISTRATION

dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

E-ZEN GARGLE 
cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62040-2001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.005 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62040-2001-1	12 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/08/2014

Labeler - JN Pharm (689048618)

Registrant - JN Pharm (689048618)

Establishment
Name	Address	ID/FEI	Business Operations
JN Pharm		689048618	manufacture(62040-2001)