CHLORHEXIDINE GLUCONATE- antiseptic skin cleanser gel

CHLORHEXIDINE GLUCONATE by

Drug Labeling and Warnings

CHLORHEXIDINE GLUCONATE by is a Otc medication manufactured, distributed, or labeled by McKesson. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient
Chlorhexidine gluconate 4% solution

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

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
• Skin wound and general skin cleansing

WARNINGS

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

WARNING: This product can expose you
to coconut oil diethanolamine
condensate (cocamide diethanolamine),
which is known to the State of California
to cause cancer. For more information
go to www.P65Warnings.ca.gov.

STOP USE

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

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

DOSAGE & ADMINISTRATION

Directions

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

Surgical hand s crub:

• 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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

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

QUESTIONS

Questions?
General Questions? Call 1-800-777-4908
Technical Support? Call 1-800-587-3721

PRINCIPAL DISPLAY PANEL

NDC: 68599-5400-2
McKesson
Antiseptic Skin Cleanser
4% CHLORHEXIDINE GLUCONATE SOLUTION
A non-sterile solution that reduces the number of
microorganisms on the skin prior to surgery or patient care.
0.5 fl oz
(15 mL)
50
PER BOX
FOR SINGLE-USE
MFR # 16-CHG15

INGREDIENTS AND APPEARANCE

CHLORHEXIDINE GLUCONATE 
antiseptic skin cleanser gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-5400
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)
PEG-75 LANOLIN (UNII: 09179OX7TB)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIDECYL ALCOHOL (UNII: 8I9428H868)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-5400-3	10 in 1 CASE	03/12/2018
1	NDC: 68599-5400-2	50 in 1 BOX
1	NDC: 68599-5400-1	15 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	03/12/2018

Labeler - McKesson (023904428)