Comp Cardinal Health Leader 4% Chg 8oz

Comp Cardinal Health Leader 4% Chg 8oz
SPL v4
SPL
SPL Set ID 7a7aeecf-ce26-5a66-e053-2991aa0ad4a2
Route
TOPICAL
Published
Effective Date 2018-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Completed Since 2012-01-01 Until 2027-02-28

Description

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% solution

Pdp

NDC 70000-0407-1

Leader

Antisptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial Skin Cleanser

Great For Hand Hygiene

For Skin Wound and General Skin Cleansing

Compare To Hibiclens® active ingredients*

For External Use Only

8 fl (237 mL)

Tampering evident:

Do not use if shrink seal neackband is broken or missing

CIN 5454889 REV. 8/23

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing
Section 60561-8

Laundering/cleaning instructions:

Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

*This product is not manufactured or districuted by Regent Medical Limited (United Kingdom Corp.), owner of the registered trademark Hibiclens ®.

WARNING: Cancer - www.P65Warnings.ca.gov

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 of 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:

  • 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 this product
  • in contact with meninges
  • in the genital area
Questions?

1-800-587-3721

Active Ingredient

Chlorhexidine gluconate 4% solution

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

Inactive Ingredients

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

When Using This Product
  • keep out of eyes, ears and mouth. May cause serious and permenant 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 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

Pdp (PDP)

NDC 70000-0407-1

Leader

Antisptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial Skin Cleanser

Great For Hand Hygiene

For Skin Wound and General Skin Cleansing

Compare To Hibiclens® active ingredients*

For External Use Only

8 fl (237 mL)

Tampering evident:

Do not use if shrink seal neackband is broken or missing

CIN 5454889 REV. 8/23

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing
Section 60561-8 (60561-8)

Laundering/cleaning instructions:

Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

*This product is not manufactured or districuted by Regent Medical Limited (United Kingdom Corp.), owner of the registered trademark Hibiclens ®.

WARNING: Cancer - www.P65Warnings.ca.gov

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 of 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:

  • 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 this product
  • in contact with meninges
  • in the genital area
Questions?

1-800-587-3721

Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

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

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)
  • keep out of eyes, ears and mouth. May cause serious and permenant 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 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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