CHLORHEXIDINE GLUCONATE
McKesson Antiseptic Skin Cleanser
673abf62-7774-6af1-e053-2a91aa0afc52
HUMAN OTC DRUG LABEL
May 19, 2025
McKesson
DUNS: 023904428
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ANTISEPTIC SKIN CLEANSER
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.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
INDICATIONS & USAGE SECTION
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
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Chlorhexidine gluconate 4% solution
OTC - PURPOSE SECTION
Purpose
Antiseptic
WARNINGS SECTION
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.
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
Inactive ingredients
cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose,
isopropyl alcohol, lauramine
oxide, PEG-75 lanolin, purified water, tridecyl alcohol
OTC - QUESTIONS SECTION
Questions?
General Questions? Call 1-800-777-4908
Technical Support? Call 1-800-587-3721