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HIBICLENS ® Antiseptic/Antimicrobial Skin Cleanser (4% chlorhexidine gluconate)

DESCRIPTION
HIBICLENS is an antiseptic antimicrobial skin cleanser possessing bactericidal activities. HIBICLENS contains 4% w/v chlorhexidine gluconate, with inactive ingredients: Fragrance, isopropyl alcohol 4%, purified water, Red 40, and other ingredients, in a mild, sudsing base adjusted to pH 5.0-6.5 for optimal activity and stability as well as compatibility with the normal pH of the skin.

ACTION
HIBICLENS is bactericidal on contact. It has antiseptic activity and a persistent antimicrobial effect with rapid bactericidal activity against a wide range of microorganisms, including gram-positive bacteria and gram-negative bacteria such as Pseudomonas aeruginosa. The effectiveness of HIBICLENS is not significantly reduced by the presence of organic matter, such as blood.¹ In a study ² simulating surgical use, the immediate bactericidal effect of HIBICLENS after a single six-minute scrub resulted in a 99.9% reduction in resident bacterial flora, with a reduction of 99.98% after the eleventh scrub. Reductions on surgically gloved hands were maintained over the six-hour test period. HIBICLENS displays persistent antimicrobial action. In one study 2, 93% of a radiolabeled formulation of HIBICLENS remained present on uncovered skin after five hours. HIBICLENS helps prevent skin infection thereby reducing the risk of cross-infection.

INDICATIONS
HIBICLENS is indicated for use as a surgical hand scrub, as a health-care personnel handwash, as a patient pre-operative skin preparation, and as a skin wound cleanser and general skin cleaner.

SAFETY
The extensive use of chlorhexidine gluconate for over 20 years outside the United States has produced no evidence of absorption of the compound through intact skin. The potential for producing skin reactions is extremely low.

WARNINGS
FOR EXTERNAL USE ONLY. KEEP OUT OF EYES, EARS AND MOUTH. HIBICLENS SHOULD NOT BE USED AS A PREOPERATIVE SKIN PREPARATION OF THE FACE OR HEAD. MISUSE OF HIBICLENS HAS BEEN REPORTED TO CAUSE SERIOUS AND PERMANENT EYE INJURY WHEN IT HAS BEEN PERMITTED TO ENTER AND REMAIN IN THE EYE DURING SURGICAL PROCEDURES. IF HIBICLENS SHOULD CONTACT THESE AREAS, RINSE OUT PROMPTLY AND THOROUGHLY WITH WATER.

Avoid contact with meninges. HIBICLENS should not be used by persons who have a sensitivity to it or its components. Chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated eardrums. Irritation, sensitization, and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas. If adverse reactions occur, discontinue use immediately and if severe, contact a physician. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Accidental ingestion: Chlorhexidine gluconate taken orally is poorly absorbed. Treat with gastric lavage using milk, egg white, gelatin or mild soap. Employ supportive measures as appropriate. Avoid excessive heat (above 104°F).

DIRECTIONS FOR USE
Skin Wound and General Skin Cleansing Wounds which involve more than the superficial layers of the skin should not be routinely treated with HIBICLENS. To use, thoroughly rinse the area to be cleansed with water. Apply the minimum amount of HIBICLENS necessary to cover the skin or wound area and wash gently. Rinse again thoroughly. Preoperative Skin Preparation Apply HIBICLENS liberally to surgical site and swab for at least two minutes. Dry with a sterile towel. Repeat procedure for an additional two minutes and dry with a sterile towel.

HEALTH-CARE PERSONNEL USE
Surgical Hand Scrub
Directions for use of HIBICLENS Antiseptic/Antimicrobial Skin Cleanser: Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL of HIBICLENS and a wet brush, paying particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be used. Rinse thoroughly. Wash for an additional 3 minutes with 5 mL of HIBICLENS and rinse under running water. Dry thoroughly.

Personnel Hand Wash
Wet hands with warm water. (Avoid using very cold or very hot water.) Dispense about 5 mL of HIBICLENS into cupped hands. Wash for 15 seconds. (Do not use excessive pressure to produce additional lather.) Rinse thoroughly with warm water. Dry thoroughly.

IMPORTANT LAUNDERING ADVICE FOR HOSPITAL STAFF AND OTHER USERS OF ANTISEPTIC PATIENT SKIN PREPARATIONS CONTAINING CHLORHEXIDINE GLUCONATE

When laundered with chlorine bleach, the combination of Chlorhexidine gluconate (CHG) and sufficient chlorine can stain fabrics. Thus, special laundering procedures should be considered when fabrics contaminated with CHG are laundered. If sufficient available chlorine is present during the washing procedure, a fast brown stain may develop due to a chemical reaction between CHG and chlorine.

SUGGESTED LAUNDERING PROCEDURES TO LIMIT STAINING

1. Not Aging. Avoid allowing the product to age (set) on unwashed linens.

2. Rinsing and Washing. A rinse operation as the initial step in the wash process is helpful in the laundering of linen exposed to chlorhexidine gluconate. Such rinsing is also important in the laundering of linen which contains organic materials such as blood or pus. For best results, warm water rinses (90-100°F) are recommended. After a number of initial rinses followed by a washing with a low alkaline/nonchlorine detergent, most fabrics previously contacting chlorhexidine gluconate should have an acceptable level of whiteness. If a rewash process using bleach is necessary to achieve a greater degree of whiteness, the bleach should be a nonchlorine bleach.

3. Not Using Chlorine Bleach. Modern laundering methods often make the use of chlorine bleach unnecessary. It is worthwhile trying to wash without chlorine to ascertain if the resulting degree of whiteness is acceptable. Omission of chlorine from the laundering process can extend the useful life of cotton articles since oxidizing bleaches such as chlorine may cause some damage to cellulose - even when used in low concentration.

4. Changing to a Peroxide-Type Bleach, Such as Sodium Perborate, Sodium Percarbonate or Hydrogen Peroxide. This should eliminate the reaction which could occur with the use of chlorine bleaches. If a chlorine bleach must be used, a concentration of less than 7 ppm available chlorine (1/10 the normal bleach level) is suggested to minimize possible staining.

A NOTE ON LAUNDERING OF PERSONAL CLOTHING

The laundering procedures set forth above using low alkaline, non-chlorine laundry detergents are also applicable to laundering of uniforms and lab coats. Commercially available laundry detergents which do not contain chlorine include Borax, Borateem®, Dreft®, Oxydol and Ivory Snow®. These products, however, will not remove stains previously set into the fabric.

RECLAMATION OF STAINED LINENS

For these linens which previously have been stained due to the chemical reaction between chlorhexidine gluconate and chlorine, the following laundering procedure may be helpful in reducing the visible stain:

Operation	Water Level	Temperature	Time (Min)	Supplies/100 lb
Break	Low	180°F	20	1.5 lb oxalic acid
Flush	High	Cold	1	--------
Emulsify	Low	160°F	5	18 oz emulsifier
Flush	High	Cold	1	--------
Bleach	Low	180°F	20	2 lb alkali builder and 1 lb organic bleach
Rinse	High	Cold	1	--------
Antichlor	High	Cold	2	4 oz antichlor
Rinse	High	Cold	1	--------
Rinse	High	Cold	1	--------
Sour	Low	Cold	4	2 oz rust removing sour

HOW SUPPLIED
For general hand washing locations: pocket-size, 15 mL foil packettes; plastic disposable bottles of 4 oz and 8 oz with dispenser caps; and 16 oz filled globes. For surgical scrub areas: plastic disposable bottles of 32 oz and 1 gal. The 32-oz bottle is designed for a special foot-operated wall dispenser. A hand-operated wall dispenser is available for the 16-oz globe. Hand pumps are available for 16 oz, 32 oz, and 1 gal sizes. Store at controlled room temperature 20-25°C (68-77°F) [see USP].
Liquid: NDC 0234-057504, 0234-057508, 0234-057516, 0234-057532, & 0234-057591).

REFERENCES
¹ Lowbury, EJL and Lilly, HA: The effect of blood on disinfection of surgeons' hands, Brit. J. Surg. 61:19-21 (Jan.) 1974
² Peterson AF, Rosenberg A, Alatary SD: Comparative evaluation of surgical scrub preparations, Obstet, 146:63- 65 (Jan.) 1978

For more information, call 800.843.8497