Mckesson Antiseptic Skin Cleanser

Mckesson Antiseptic Skin Cleanser
SPL v7
SPL
SPL Set ID 673abf62-7774-6af1-e053-2a91aa0afc52
Route
TOPICAL
Published
Effective Date 2018-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Completed Since 2018-03-12 Until 2026-07-31

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and 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
Dosage and 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
Description

Drug Facts

Section 42229-5

Drug Facts

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

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.

Section 51727-6

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine

oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Section 51945-4

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

Section 53413-1

Questions?

General Questions? Call 1-800-777-4908

Technical Support? Call 1-800-587-3721

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Chlorhexidine gluconate 4% solution

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

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)

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.

Section 51727-6 (51727-6)

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine

oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions?

General Questions? Call 1-800-777-4908

Technical Support? Call 1-800-587-3721

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Chlorhexidine gluconate 4% solution

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)