FDA Label for Antiseptic Skin Cleanser

Otc - 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: preparation of the patient's skin prior to surgery
• skin wound and general 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
• wound 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.

Direction

• 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 with 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 throughly
• wash for an additional 3 minutes with 5 ml of product into cupped hands and washin a vigorous manner for 15 seconds seconds
• rinse and 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 and dry with a sterile towel
• repeat procecedure 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

Packaging

NDC 59779-765-08

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

4CVSBTLLBLF

8FL OZ (237mL)

NDC 59779-765-16

Chlorhexidine Gluconate 4% Solution

Antiseptic Skin Cleanser

Distributed by:

CVS Pharmacy, Inc.

Woonsocket, RI 02985

4CVS16BTLLBL

16FL OZ (473mL)