NDC Code(s) : 0116-1061-08, 0116-1061-16, 0116-1061-32, 0116-1061-01, 0116-1061-40, 0116-1061-18
Packager : Xttrium Laboratories, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSERCHLORHEXIDINE GLUCONATE SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-1061
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 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
WATER(UNII: 059QF0KO0R)
TRIDECYL ALCOHOL(UNII: 8I9428H868)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
PEG-75 LANOLIN(UNII: 09179OX7TB)
COCO DIETHANOLAMIDE(UNII: 92005F972D)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0116-1061-08237 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
2NDC:0116-1061-16437 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
3NDC:0116-1061-32946 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2011
4NDC:0116-1061-0115142 mL in 1 JUG Type 0: Not a Combination Product31/08/2011
5NDC:0116-1061-40118 mL in 1 BOTTLE Type 0: Not a Combination Product01/01/2019
6NDC:0116-1061-18532 mL in 1 BOTTLE Type 0: Not a Combination Product31/08/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 08/31/2011

LABELER - Xttrium Laboratories, Inc.(007470579)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name Address ID/FEI Business Operations
Xttrium Laboratories, Inc. 007470579 manufacture(0116-1061)

PRINCIPAL DISPLAY PANEL

NDC 0116-1061-08

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 8 fl oz (237 mL)

4DY08BTLLBLF

4 Dyna-Hex 8oz Single Panel

NDC 0116-1061-16

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 16 fl oz (473 mL)

4DY16BTLLBLF

4 Dyna-Hex 8oz Single Panel

NDC 0116-1061-32

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 32 fl oz (946 mL)

4DY32BTLLBLB

4 Dyna-Hex 8oz Single Panel

NDC 0116-1061-01

DYNA-HEX 4 ®

(Chlorhexidine Gluconate 4% Solution)

Antiseptic

Contains: 4% Chlorhexidine Gluconate

Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 128 fl oz (1 gal)

4DYN1GBTLLBLC

4 Dyna-Hex 8oz Single Panel

NDC 0116-1061-40

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate With foam pump

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 4 fl oz (118mL)

4DY04FM1061LBLB

4 Dyna-Hex 8oz Single Panel

NDC 0116-1061-18

DYNA-HEX 4®

Chlorhexidine Gluconate 4% Solution

Antiseptic

Contains:

4% Chlorhexidine Gluconate

Distributed By:

Xttrium Laboratories, Inc.

Mount Prospect, IL 60056

FOR EXTERNAL USE ONLY

Net Contents: 18 fl oz (532mL)

4DY18FM1061LBLB

4 Dyna-Hex 8oz Single Panel