drug facts

drug facts
SPL v3
SPL
SPL Set ID 6a77ef12-825d-4b37-8c1c-6540bf7970c4
Route
topical
Published
Effective Date 2010-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlorhexidine (2 g)
Inactive Ingredients
anhydrous citric acid cocamide diethanolamine hydroxyethyl cellulose (140 cps at 5%) isopropyl alcohol lauramine oxide water

Identifiers & Packaging

Marketing Status
nda active Since 1998-09-01

Description

Active ingredient Chlorhexidine Gluconate 2% solution


Medication Information

Warnings and Precautions
Warning

For external use only

Active Ingredient

Active ingredient

Chlorhexidine Gluconate 2% solution

Dosage and Administration

Directions

Surgical hand scrub

  • wet hands and forearms under running 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
  • 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

Description

Active ingredient Chlorhexidine Gluconate 2% solution

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

  • 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

2% Chlorhexidine Gluconate, 4 oz.

Section 53413-1

Questions or comments?

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

Section 55105-1

Purpose

Surgical hand scrub

Healthcare personnel handwash

Patient preoperative skin preparation

Skin wound and general skin cleansing


Structured Label Content

Warnings and Precautions (34071-1)
Warning

For external use only

Active Ingredient (55106-9)

Active ingredient

Chlorhexidine Gluconate 2% solution

Dosage and Administration (34068-7)

Directions

Surgical hand scrub

  • wet hands and forearms under running 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
  • 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

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

  • 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)

2% Chlorhexidine Gluconate, 4 oz.

Section 53413-1 (53413-1)

Questions or comments?

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

Section 55105-1 (55105-1)

Purpose

Surgical hand scrub

Healthcare personnel handwash

Patient preoperative skin preparation

Skin wound and general skin cleansing


Advanced Ingredient Data


Raw Label Data

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