Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID 45c1e1b3-6d56-4fa2-a332-4e88d2f416dc
Route
TOPICAL
Published
Effective Date 2014-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Coco Diethanolamide Gluconolactone Hydroxyethyl Cellulose (140 Cps At 5%) Isopropyl Alcohol Lauramine Oxide Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1998-09-01

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

Section 50567-7

When using this product

  • single use when used for patient preoperative skin preparation
  • 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 installed in the middle ear through perforated ear drums.
  • 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
Section 50570-1

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin prep of the head or face

Section 51945-4

4% Chlorhexidine Gluconate

Section 53413-1

Questions or comments?

1-800-760-3236 (Mon.-Fri. 8:30AM - 5:00 PM EST)

Warnings

For external use only

Directions

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

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product with 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 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

Active Ingredient

Chlorhexidine Gluconate 4% solution

Inactive Ingredients

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


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

Section 50567-7 (50567-7)

When using this product

  • single use when used for patient preoperative skin preparation
  • 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 installed in the middle ear through perforated ear drums.
  • 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
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin prep of the head or face

Section 51945-4 (51945-4)

4% Chlorhexidine Gluconate

Section 53413-1 (53413-1)

Questions or comments?

1-800-760-3236 (Mon.-Fri. 8:30AM - 5:00 PM EST)

Purpose

Antiseptic

Warnings

For external use only

Directions

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

Surgical hand scrub:

  • wet hands and forearms with water
  • scrub for 3 minutes with about 5 mL of product with 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 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

Active Ingredient (Active ingredient)

Chlorhexidine Gluconate 4% solution

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

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