Antiseptic Skin Cleanser

Antiseptic Skin Cleanser
SPL v10
SPL
SPL Set ID 626d7aa9-b8da-4254-9c57-9007ed4290d4
Route
TOPICAL
Published
Effective Date 2017-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Coco Diethanolamide Gluconolactone Hydroxyethyl Cellulose (100 Mpa.s At 2%) Isopropyl Alcohol Lauramine Oxide Peg-75 Lanolin Water Tridecyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Completed Since 2017-06-01 Until 2026-08-31

Description

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% solution

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
Section 50565-1

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

Section 50566-9

Stop use and ask doctor ifirritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Warnings

For external use only

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
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
Questions?

General Questions? Call 1-800-777-4908

Technical Support? Call 1-800-587-3721

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.

Active Ingredient

Chlorhexidine gluconate 4% solution

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

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
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
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
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
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

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


Structured Label Content

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
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor ifirritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Warnings

For external use only

Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Do Not Use (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
Questions?

General Questions? Call 1-800-777-4908

Technical Support? Call 1-800-587-3721

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.

Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

Other Information (Other information)
  • store at 68-77ºF (20-25°C)
  • avoid excessive heat above 104°F (40°C)
Inactive Ingredients (Inactive ingredients)

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

When Using This Product (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
Healthcare Personnel Handwash: (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
Skin Wound and General Skin Cleaning: (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
Patient Preoperative Skin Preparation: (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
Principal Display Panel Mckesson Antiseptic Skin Cleanser 1 Gal Bottle Label (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

Principal Display Panel Mckesson Antiseptic Skin Cleanser 4 Fl Oz Bottle Label (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 (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 (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 (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


Advanced Ingredient Data


Raw Label Data

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