NDC Code(s) : 63868-940-08
Packager : Chain Drug Marketing Association Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Antiseptic Skin CleanserChlorhexidine Gluconate 4% LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-940
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E)
(CHLORHEXIDINE - UNII:R4KO0DY52L) 		CHLORHEXIDINE GLUCONATE4 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
COCO DIETHANOLAMIDE(UNII: 92005F972D)
PEG-75 LANOLIN(UNII: 09179OX7TB)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
WATER(UNII: 059QF0KO0R)
TRIDECYL ALCOHOL(UNII: 8I9428H868)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63868-940-08237 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 05/01/2014

LABELER - Chain Drug Marketing Association Inc.(011920774)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name Address ID/FEI Business Operations
Xttrium Laboratories, Inc. 007470579 manufacture(63868-940)

PRINCIPAL DISPLAY PANEL

Quality Choice

NDC 63868-940-08

Compare to the active ingredient in HIBICLENS®*

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Reduces Bacteria on the Skin

Net Contents: 8FL OZ (237 mL) BOTTLE

FOR EXTERNAL USE ONLY

DYE FREE

1061QC08LBLG

Quality Choice Single Panel