FDA Label for Antiseptic Skin Cleanser

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

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

Warnings

For external use only

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 preparation of the head or face

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 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 the underlying condition makes it necessary to reduce the bacterial population of the skin

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.

Directions

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

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

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

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

Other Information

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

Inactive Ingredients

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

Questions Of Comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

Other Safety Information

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®.

Package Label And Principal Display Panel

NDC 36800-401-50

TopCare®

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

Antiseptic/Antimicrobial Skin Cleanser

FOR EXTERNAL USE ONLY

DYE FREE

Compare to the active ingredient in Hibiclens®*

8FL OZ. (237 mL)