NDC Code(s) : 0116-3678-08, 0116-3678-07
Packager : Xttrium Laboratories, 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:0116-3678
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:0116-3678-08237 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/01/2013
2NDC:0116-3678-07473 mL in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 01/01/2013

LABELER - Xttrium Laboratories, Inc.(007470579)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name Address ID/FEI Business Operations
Xttrium Laboratories, Inc. 007470579 manufacture(0116-3678)

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Hibiclens®

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE 4% SOLUTION

dye free

for external use only

TAMPER-EVIDENT:

DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

8 FL OZ (237 mL)

4RA08BTLLBLJ

Rite Aid 8oz Single Panel

Compare to the active ingredient in Hibiclens®

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE 4% SOLUTION

dye free

for external use only

TAMPER-EVIDENT:

DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

16 FL OZ (473 mL)

4RA16BTLLBLC

Rite Aid 8oz Single Panel