FDA Label for Aplicare Antiseptic Chlorhexidine Gluconate

Purposes

surgical hand scrub

healthcare personnel handwash

patient preoperative skin preparation

skin wound and general skin cleansing

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
• healthcare personnel handwash: handwash to help 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

Otc - Do Not Use

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

Otc - When Using

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 ear drums.
• if solution should contact these areas, rinse out promptly and thoroughly with water
• wounds which involve more than the superficial layers 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

Otc - Stop Use

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Directions

Surgical hand scrub

• wet hands and forearms under running water for 30 seconds
• scrub for 3 minutes with about 5 mL of product with or without a wet brush, paying close attention to the nails, cuticles and interdigital spaces
• rinse thoroughly under running water for 30 seconds
• 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 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 POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions Or Comments?

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

Package Label.Principal Display Panel

4% Chlorhexidine Gluconate, 128 oz