Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
healthcare personnel handwash:helps reduce bacteria that potentially can cause disease
patient preoperative skin preparation:for the preparation of the patient's skin prior to surgery
skin wound and general skin cleansing

Warnings

For external use only

Allergy Alert

This product may cause a severe allergic reaction. Symptoms may include:

wheezing/difficulty breathing
shock
facial swelling
hives
rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

if you are allergic to chlorhexidine gluconate or any other ingredients in this product
in contact with meninges
in the genital area
as a preoperative skin preparation of the head or face

When using this product

keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums
if solution should contact these areas, rinse out promptly and thoroughly with water
wounds which involve more than the superficial layers of the skin should not be routinely treated
repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin

Stop use and ask doctor ifirritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

wet hands with water
dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
rinse and dry thoroughly

Patient preoperative skin preparation:

apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleaning:

thoroughly rinse the area to be cleaned with water
apply the minimum amount of product necessary to cover the skin or wound area and wash gently
rinse again thoroughly

Other information

store at 68-77ºF (20-25°C)
avoid excessive heat above 104°F (40°C)

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions?

General Questions? Call 1-800-777-4908

Technical Support? Call 1-800-587-3721

Principal Display Panel - McKesson Antiseptic Skin Cleanser 4 fl oz Bottle Label

NDC 68599-5401-2

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 - McKesson Antiseptic Skin Cleanser 8 fl oz Bottle Label

NDC 68599-5401-3

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 - McKesson Antiseptic Skin Cleanser 16 fl oz Bottle Label

NDC 68599-5401-4

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 - McKesson Antiseptic Skin Cleanser 32 fl oz Bottle Label

NDC 68599-5401-5

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

Principal Display Panel - McKesson Antiseptic Skin Cleanser 1 gal Bottle Label

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

ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68599-5401
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68599-5401-1	48 in 1 CASE	06/01/2017
1	NDC:68599-5401-2	118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:68599-5401-7	24 in 1 CASE	06/01/2017
2	NDC:68599-5401-3	237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:68599-5401-8	12 in 1 CASE	06/01/2017
3	NDC:68599-5401-4	473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:68599-5401-9	12 in 1 CASE	06/01/2017
4	NDC:68599-5401-5	946 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:68599-5401-0	4 in 1 CASE	06/01/2017
5	NDC:68599-5401-6	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019125	06/01/2017

Labeler - McKesson Medical-Surgical (023904428)

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