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CHLORHEXIDINE GLUCONATE

McKesson Antiseptic Skin Cleanser

Approved
Approval ID

673abf62-7774-6af1-e053-2a91aa0afc52

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 2025

Manufacturers
FDA

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
NDC Product Code68599-5400
Application NumberNDA019125
Product Classification
M
Marketing Category
C73594
G
Generic Name
ANTISEPTIC SKIN CLEANSER
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 19, 2025
FDA Product Classification

INGREDIENTS (9)

TRIDECYL ALCOHOLInactive
Code: 8I9428H868
Classification: IACT
CHLORHEXIDINE GLUCONATEActive
Quantity: 4 g in 100 mL
Code: MOR84MUD8E
Classification: ACTIB
COCO DIETHANOLAMIDEInactive
Code: 92005F972D
Classification: IACT
PEG-75 LANOLINInactive
Code: 09179OX7TB
Classification: IACT
GLUCONOLACTONEInactive
Code: WQ29KQ9POT
Classification: IACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)Inactive
Code: R33S7TK2EP
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/29/2018

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

16-CHG15

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/12/2018

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

LOINC: 42229-5Updated: 3/12/2018

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/12/2018

Active ingredient
Chlorhexidine gluconate 4% solution

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/12/2018

Purpose
Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 3/12/2018

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

LOINC: 50566-9Updated: 3/12/2018

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

LOINC: 50565-1Updated: 3/12/2018

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/12/2018

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

LOINC: 60561-8Updated: 3/12/2018

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/12/2018

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/12/2018

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

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CHLORHEXIDINE GLUCONATE - FDA Drug Approval Details