Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID cff86968-3f0d-4b58-afad-2bdc746f8f82
Route
TOPICAL
Published
Effective Date 2019-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (40 g)
Inactive Ingredients
Gluconolactone Isopropyl Alcohol Lauramine Oxide Peg-75 Lanolin Coco Diethanolamide Water Tridecyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Completed Since 2006-01-01 Until 2025-10-31

Description

Chlorhexidine gluconate 4% solution

Purpose

surgical hand scrub healthcare personnel handwash


Medication Information

Purpose

surgical hand scrub healthcare personnel handwash

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
Section 42229-5

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.

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 a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Purposes

surgical hand scrub

healthcare personnel handwash

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 ingredient in this product

Active Ingredient

Chlorhexidine gluconate 4% solution

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

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

Surgical Hand Scrub:
  • wet hands and forearms with water
  • scrub for 3 minutes with about 2.0 cubic inches 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 2.0 cubic inches of product and rinse under running water
  • dry thoroughly
Questions Or Comments?

call 1-800-453-4538

Monday through Friday 8 AM to 5 PM EST

When Using This Product
  • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin
Healthcare Personnel Handwash:
  • wet hands with water
  • dispense about 1.5 cubic inches of product into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
  • dry thoroughly
Principal Display Panel – Box Label

NDC 17271-505-01

BD E-Z Scrub™

Chlorhexidine

Gluconate 4% Solution

Antiseptic

REF 372402

Foreign Patents and Patents Pending.

U.S. Patents 6,053,369 - 6,308,866

Chlorhexidine Gluconate

32 fl oz (946 mL)


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
Section 42229-5 (42229-5)

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.

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 a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Purposes

surgical hand scrub

healthcare personnel handwash

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 ingredient in this product

Active Ingredient

Chlorhexidine gluconate 4% solution

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

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

Surgical Hand Scrub: (Surgical hand scrub:)
  • wet hands and forearms with water
  • scrub for 3 minutes with about 2.0 cubic inches 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 2.0 cubic inches of product and rinse under running water
  • dry thoroughly
Questions Or Comments? (Questions or comments?)

call 1-800-453-4538

Monday through Friday 8 AM to 5 PM EST

When Using This Product (When using this product)
  • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin
Healthcare Personnel Handwash: (Healthcare personnel handwash:)
  • wet hands with water
  • dispense about 1.5 cubic inches of product into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
  • dry thoroughly
Principal Display Panel – Box Label

NDC 17271-505-01

BD E-Z Scrub™

Chlorhexidine

Gluconate 4% Solution

Antiseptic

REF 372402

Foreign Patents and Patents Pending.

U.S. Patents 6,053,369 - 6,308,866

Chlorhexidine Gluconate

32 fl oz (946 mL)


Advanced Ingredient Data


Raw Label Data

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