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Antiseptic Skin Cleanser Prescribing Information

Package insert / product label
Generic name: chlorhexidine gluconate
Dosage form: topical solution
Drug classes: Antiseptic and germicides, Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Feb 15, 2024.

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Indications and Usage for Antiseptic Skin Cleanser

  • 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.

Antiseptic Skin Cleanser Dosage and Administration

  • 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

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-CHG4CHG4

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

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

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-CHG3216-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 TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-5401-148 in 1 CASE06/01/2017
1NDC:68599-5401-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68599-5401-724 in 1 CASE06/01/2017
2NDC:68599-5401-3237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68599-5401-812 in 1 CASE06/01/2017
3NDC:68599-5401-4473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68599-5401-912 in 1 CASE06/01/2017
4NDC:68599-5401-5946 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:68599-5401-04 in 1 CASE06/01/2017
5NDC:68599-5401-63800 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912506/01/2017
Labeler - McKesson Medical-Surgical (023904428)
Establishment
NameAddressID/FEIBusiness Operations
XTTRIUM LABORATORIES, INC.007470579manufacture(68599-5401)

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