Xtt 8oz Leader 4% Chg

Xtt 8oz Leader 4% Chg
SPL v8
SPL
SPL Set ID 4a9eda34-d85c-4b66-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2023-12-14
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2012-01-01

Description

Chlorhexidine gluconate 4% Solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% Solution

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing
Section 43683-2

Indications and Usage

Dosage and Administration

Directions (12/14)

uses

Section 60561-8

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 fo to www.P65Warnings.ca.gov.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

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

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

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleansing:

  • throughly 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 this product
  • in contact with meninges
  • in the genital area
Active Ingredient

Chlorhexidine gluconate 4% Solution

Other Information
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
Principal Display

LEADER

NDC 70000-0407-1

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic / Antimicrobial Skin Cleanser

For External Use Only

COMPARE TO HIBICLENS ® active ingredient*

100% Money Back Guarantee

8 fl oz (237 mL)

4LEAD08BTLLBLE

Inactive Ingredients

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

Questions Or Comments?

1-800-587-3721

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 of 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.
Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing
Section 43683-2 (43683-2)

Indications and Usage

Dosage and Administration

Directions (12/14)

uses

Section 60561-8 (60561-8)

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 fo to www.P65Warnings.ca.gov.

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

Purpose

Antiseptic

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

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

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and general skin cleansing:

  • throughly 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 this product
  • in contact with meninges
  • in the genital area
Active Ingredient

Chlorhexidine gluconate 4% Solution

Other Information (Other information)
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
Principal Display

LEADER

NDC 70000-0407-1

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic / Antimicrobial Skin Cleanser

For External Use Only

COMPARE TO HIBICLENS ® active ingredient*

100% Money Back Guarantee

8 fl oz (237 mL)

4LEAD08BTLLBLE

Inactive Ingredients (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?)

1-800-587-3721

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 of 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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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Raw Label Data

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