E-ZEN GARGLE- cetylpyridinium chloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)

Available from:

JN Pharm

INN (International Name):

CETYLPYRIDINIUM CHLORIDE

Composition:

CETYLPYRIDINIUM CHLORIDE 0.005 g in 100 mL

Administration route:

DENTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Plaque removal. Mouth cleanliness, Halitosis removal -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.

Authorization status:

unapproved drug other

Summary of Product characteristics

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
JN Pharm
E-ZEN GARGLE
cetylpyridinium chloride liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 20 40 -20 0 1
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P) (CETYLPYRIDINIUM -
UNII:CUB7JI0 JV3)
CETYLPYRIDINIUM
CHLORIDE
0 .0 0 5 g
in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
XYLITO L (UNII: VCQ0 0 6 KQ1E)
SO DIUM CITRATE (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 20 40 -20 0 1-1
12 mL in 1 POUCH
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 2/0 8 /20 14
LABELER -
JN Pharm (689048618)
REGISTRANT -
JN Pharm (689048618)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
JN Pharm
6 8 9 0 48 6 18
ma nufa c ture (6 20 40 -20 0 1)
Revised: 2/2014