Comp Quality Choice 4% 8oz

Comp Quality Choice 4% 8oz
SPL v7
SPL
SPL Set ID 12234b17-fd07-6088-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Completed Since 2014-05-01 Until 2027-02-28

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 60561-8

Warning: Cancer - www.P65Warnings.gov

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 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 5ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and normal 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
Other Information

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

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®.

Other Information
  • store at 20°-25° C (68°-77° F)
  • avoid excessive heat above 40° C (104° F)
Active Ingredients

Chlorhexidine gluconate 4% solution

Inactive Ingredients

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

Questions of 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 procider
Stop Use and Ask 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

Package Label and Principal Display Panel

Quality Choice

NDC 63868-940-08

Compare to the active ingredient in HIBICLENS®*

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Reduces Bacteria on the Skin

Net Contents: 8FL OZ (237 mL) BOTTLE

FOR EXTERNAL USE ONLY

DYE FREE

1061QC08LBLG


Structured Label Content

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

Warning: Cancer - www.P65Warnings.gov

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 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 5ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Skin wound and normal 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
Other Information

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

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®.

Other Information (Other information)
  • store at 20°-25° C (68°-77° F)
  • avoid excessive heat above 40° C (104° F)
Active Ingredients

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.

Questions of Comments? (Questions of 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 procider
Stop Use and Ask Doctor If (Stop use and ask 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

Package Label and Principal Display Panel (Package label and principal display panel)

Quality Choice

NDC 63868-940-08

Compare to the active ingredient in HIBICLENS®*

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Reduces Bacteria on the Skin

Net Contents: 8FL OZ (237 mL) BOTTLE

FOR EXTERNAL USE ONLY

DYE FREE

1061QC08LBLG


Advanced Ingredient Data


Raw Label Data

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