Drug Facts Cf Eto

Drug Facts Cf Eto
SPL v5
SPL
SPL Set ID d28b205d-e3af-488e-86e9-caa766998390
Route
TOPICAL
Published
Effective Date 2015-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 mg)
Inactive Ingredients
Lauramine Oxide Coco Diethanolamide Gluconolactone Hydroxyethyl Cellulose (2000 Cps At 1%) Tridecyl Alcohol Peg-75 Lanolin Water Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
NDA Active Since 2012-11-01

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 hand and forearms prior to surgery or patient care
  • healthcare personnel hand wash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: preparation of the patient’s skin prior to surgery
  • skin wound and general skin cleansing
Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Antiseptic



Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away

Direction

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

Surgical hand scrub:

  • wet arms 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 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
  • dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing:

  • 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
Do Not Use
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in thus product
  • in contact with meninges
  • in genital area
  • as a preoperative skin preparation of the head or face
Active Ingredient

Chlorhexidine Gluconate 4% Solution

Other Information
  • Store at 20-25º C (68-77ºF)
  • Avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients

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

Questions Or Comments?

Call 1-800-587-3721

Monday through Friday 8:00 AM to 4:30 PM CST

Principal Display Panel

NDC 0116-2994

BD Scrub Care™

Exidine™ - 4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

For Single Use Only

Distributed By

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10081 Rev. A

ETOBTLLBLE

Net Contents: 4 fl oz (118 mL)

Stop Use and Ask Doctor

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

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
  • wounds which involve more than the superficial layers if the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Structured Label Content

Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hand and forearms prior to surgery or patient care
  • healthcare personnel hand wash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: preparation of the patient’s skin prior to surgery
  • skin wound and general skin cleansing
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Antiseptic



Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away

Direction

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

Surgical hand scrub:

  • wet arms 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 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
  • dry with a sterile towel
  • repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing:

  • 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
Do Not Use (Do not use)
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in thus product
  • in contact with meninges
  • in genital area
  • as a preoperative skin preparation of the head or face
Active Ingredient

Chlorhexidine Gluconate 4% Solution

Other Information
  • Store at 20-25º C (68-77ºF)
  • Avoid excessive heat above 40ºC (104ºF)
Inactive Ingredients

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

Questions Or Comments? (Questions or comments?)

Call 1-800-587-3721

Monday through Friday 8:00 AM to 4:30 PM CST

Principal Display Panel

NDC 0116-2994

BD Scrub Care™

Exidine™ - 4 CHG 4%

Chlorhexidine Gluconate 4% Solution

Antiseptic

Non-sterile Solution

Contains:

4% Chlorhexidine Gluconate

For External Use Only

For Single Use Only

Distributed By

Becton, Dickinson and Company

Vernon Hills, IL 60061 USA

51-10081 Rev. A

ETOBTLLBLE

Net Contents: 4 fl oz (118 mL)

Stop Use and Ask Doctor (Stop use and ask doctor)

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

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
  • wounds which involve more than the superficial layers if the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Advanced Ingredient Data


Raw Label Data

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