ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution

Antiseptic Skin Cleanser by

Drug Labeling and Warnings

Antiseptic Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by McKesson Medical-Surgical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 if irritation, 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.

Surgical hand scrub:

• wet hands and forearms with water
• scrub for 3 minutes with about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
• a separate nail cleaner may be used
• rinse thoroughly
• wash for an additional 3 minutes with 5 mL of product and rinse under running water
• dry thoroughly

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

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

Principal Display Panel - McKesson Antiseptic Skin Cleanser 8 fl oz Bottle Label

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

Principal Display Panel - McKesson Antiseptic Skin Cleanser 16 fl oz Bottle Label

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

Principal Display Panel - McKesson Antiseptic Skin Cleanser 32 fl oz Bottle Label

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

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

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 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
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	06/01/2017

Labeler - McKesson Medical-Surgical (023904428)