NDC Code(s) : 68599-5401-2, 68599-5401-1, 68599-5401-3, 68599-5401-7, 68599-5401-4, 68599-5401-8, 68599-5401-5, 68599-5401-9, 68599-5401-6, 68599-5401-0
Packager : McKesson Medical-Surgical

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:68599-5401
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
COCO DIETHANOLAMIDE(UNII: 92005F972D)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
PEG-75 LANOLIN(UNII: 09179OX7TB)
WATER(UNII: 059QF0KO0R)
TRIDECYL ALCOHOL(UNII: 8I9428H868)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68599-5401-148 in 1 CASE 06/01/2017
1NDC:68599-5401-2118 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:68599-5401-724 in 1 CASE 06/01/2017
2NDC:68599-5401-3237 mL in 1 BOTTLE Type 0: Not a Combination Product
3NDC:68599-5401-812 in 1 CASE 06/01/2017
3NDC:68599-5401-4473 mL in 1 BOTTLE Type 0: Not a Combination Product
4NDC:68599-5401-912 in 1 CASE 06/01/2017
4NDC:68599-5401-5946 mL in 1 BOTTLE Type 0: Not a Combination Product
5NDC:68599-5401-04 in 1 CASE 06/01/2017
5NDC:68599-5401-63800 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 06/01/2017

LABELER - McKesson Medical-Surgical(023904428)

Establishment
Name Address ID/FEI Business Operations
XTTRIUM LABORATORIES, INC. 007470579 manufacture(68599-5401)

PRINCIPAL DISPLAY PANEL

NDC 68599-5401-2

4%

McKESSON

AntisepticSkin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

4 fl oz
(118 mL)

DO NOT REUSE

MFR # 16-CHG4 CHG4

PRINCIPAL DISPLAY PANEL

NDC 68599-5401-3

4%

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

8 fl oz
(237 mL)

MFR # 16-CHG8

CHG8

PRINCIPAL DISPLAY PANEL

NDC 68599-5401-4

4%

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

16 fl oz

(473 mL)

MFR # 16-CHG16

CHG16

PRINCIPAL DISPLAY PANEL

NDC 68599-5401-5

4%

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

32 fl oz
(946 mL)

MFR # 16-CHG32 16-CHG32

PRINCIPAL DISPLAY PANEL

NDC 68599-5401-6

McKESSON

Antiseptic Skin Cleanser

4% CHLORHEXIDINE GLUCONATE SOLUTION

Reduces the number of microorganisms on the skin prior to surgery or patient care.

1 gal
(3.8 L)

MFR # 16-CHGGL

CHGGL