Benzalkonium chloride (BAK) is a topical antiseptic agent. It is used as an antiseptic of the skin, mucous membranes, and wounds. Benzalkonium chloride can also be used preoperatively for preparation of the skin. Other uses include preservation of ophthalmic solutions and as an irrigation for the eye, body cavities, bladder, urethra, and for vaginal douching. BAK is a rapidly acting, cationic, surface-active, antiinfective agent with a moderately long duration of action. This drug was approved by the FDA in 1947.
General Administration Information
For storage information, see specific product information within the How Supplied section.
For benzalkonium chloride aqueous solution:
-Liberal use of the solution is recommended to compensate for any adsorption of benzalkonium chloride by cotton or other materials.
-Fabrics and fibers adsorb benzalkonium chloride and can include cotton, wool, gauze sponges, rayon, and rubber materials. Applicators or sponges intended for skin preparations should be stored separately and dipped in benzalkonium chloride immediately before use.
-Solutions should not be stored in bottles stoppered with cork closures, but in containers with appropriate screw-caps.
-Serum and protein material decrease the activity of benzalkonium chloride.
Route-Specific Administration
Topical Administration
Aqueous solution:
-Sterile water for injection is recommended for dilution when used for deep wounds or for irrigation of body cavities. Freshly distilled water is also recommended for dilution when used for traumatized tissue. Resin deionized water, stored tap water, and saline should NOT be used for dilution.
-Solutions used on inflamed or irritated tissues must be more dilute than those used on normal tissues.
-The use in occlusive dressings or casts is not recommended due to potential irritation or chemical burns.
Topical gel:
-For external use only. Avoid contact with eyes. Rinse with cool tap water if gel gets in the eyes.
-Gel may become discolored when it mixes with fluid from the wound. This is normal and not a cause for concern.
Topical foam:
-For external use only. Do not use over a large area. Avoid contact with eye. Immediately contact a Poison Control Center if swallowed.
-Use a small amount of foam and a sterile gauze to clear any dirt or debris from the affected area.
-After the affected area is clean, apply a small amount of foam. Allow the foam to dissipate into the wound. Wipe away any excess foam with a sterile gauze
-Allow foam to dry before covering with a sterile bandage.
Other Topical Formulations
For benzalkonium chloride 0.13% cold sore/fever blister tincture (non-prescription product, OTC):
-Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics (including lipstick) using warm water and a washcloth.
-Remove the cardboard top from the applicator and place onto the glass/plastic vial end which is opposite the brush end of the product.
-Squeeze the cardboard to break the inner glass vial open.
-Saturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicator.
-For best results, massage the solution into the cold sore by rubbing. Rub firmly, but do not damage the tissue.
-Hold the vial so the solution flows into the cold sore.
-Use all of the medication in the vial.
-Recap the vial and dispose of the product immediately.
-Wash your hands immediately after application with warm water and soap.
-Do not get this medicine in the eyes. Do not swallow. Do not apply to other areas of the body.
-Also, do not touch the eyes, genitals, or other parts of the body to avoid transfer of the virus.
-Avoid brushing your teeth or drinking soft drinks or fruit juices for 1 hour after application.
Extemporaneous Compounding-Topical
For preoperative surgical skin preparation with benzalkonium chloride aqueous solution:
-For preoperative preparation of the skin, an aqueous solution of 1:750 should be used. Consult the manufacturer's information regarding recipe recommendations.
-For surgeons' hand and arm soaks, an aqueous solution of 1:750 should be used.
-Solutions should not be permitted to remain in prolonged contact with the patient's skin.
-Avoid pooling on the operating table.
-Benzalkonium solutions have a tendency to "run off" the skin. It may be preferable to use alternately with alcohol in preoperative preparation of the skin.
-Preoperative periorbital skin or head preparation should be performed only before the patient, or eye, is anesthetized.
For irrigation of deep infected wounds with benzalkonium chloride aqueous solution:
-An aqueous solution of 1:3000 to 1:20,000 should be used. Consult the manufacturer's information regarding recipe recommendations.
For use of benzalkonium chloride aqueous solution on denuded skin and mucous membranes:
-An aqueous solution of 1:5000 to 1:10,000 should be used. Consult the manufacturer's information regarding recipe recommendations.
For use of benzalkonium chloride aqueous solution during post-episiotomy care:
-An aqueous solution of 1:5000 to 1:10,000 should be used. Consult the manufacturer's information regarding recipe recommendations.
For use of benzalkonium chloride aqueous solution for breast and nipple hygiene:
-An aqueous solution of 1:1000 to 1:2000 should be used. Consult the manufacturer's information regarding recipe recommendations.
For use of benzalkonium chloride aqueous solution on oozing and open infections:
-An aqueous solution of 1:2000 to 1:5000 should be used. Consult the manufacturer's information regarding recipe recommendations.
-When using wet dressings by irrigation or an open dressing, and aqueous solution of 1:5000 or less should be used. Use in occlusive dressings is inadvisable.
Intravaginal Administration
For benzalkonium chloride aqueous solution:
-Sterile water for injection is recommended for dilution when used for irrigation of body cavities. Resin de-ionized water, stored tap water, and saline should NOT be used for dilution.
-Solutions used on inflamed or irritated tissues must be more dilute than those used on normal tissues.
-Occlusive vaginal packs are NOT recommended due to the potential for irritation or chemical burns.
Extemporaneous Compounding-Vaginal
For use of benzalkonium chloride aqueous solution as a vaginal douche or for vaginal irrigation:
-An aqueous solution of 1:2000 to 1:5000 should be used. Consult the manufacturer's information regarding recipe recommendations.
Rectal Administration
Extemporaneous Compounding-Rectal
Benzalkonium chloride should NOT be used in occlusive anal packs due to the potential for irritation or chemical burns.
Ophthalmic Administration
For benzalkonium chloride aqueous solution:
-Sterile distilled water is recommended for dilution when used for irrigation of the eye. Resin de-ionized water, stored tap water, and saline should NOT be used for dilution.
-Solutions used on inflamed or irritated tissues must be more dilute than those used on normal tissues.
Extemporaneous Compounding-Ophthalmic
For use of benzalkonium chloride aqueous solution in eye irrigation:
-An aqueous solution of 1:5000 to 1:10,000 should be used. Consult the manufacturer's information regarding recipe recommendations.
For preservation of ophthalmic solutions with benzalkonium chloride aqueous solution:
-And aqueous solution of 1:5000 to 1:7500 should be used. Consult the manufacturer's information regarding recipe recommendations.
Other Administration Route(s)
For Bladder and Urethral Administration:
For benzalkonium chloride aqueous solution:
-Sterile water for injection is recommended for dilution when used for irrigation of body cavities. Resin deionized water, stored tap water, and saline should NOT be used for dilution.
-Solutions used on inflamed or irritated tissues must be more dilute than those used on normal tissues.
Extemporaneous Compounding-Other
For bladder and urethral irrigation with benzalkonium chloride aqueous solution:
-An aqueous solution of 1:5000 to 1:20,000 should be used. Consult the manufacturer's information regarding recipe recommendations.
For bladder retention lavage with benzalkonium chloride aqueous solution:
-An aqueous solution of 1:20,000 to 1:40,000 should be used. Consult the manufacturer's information regarding recipe recommendations.
Benzalkonium chloride aqueous solutions in normally used concentrations have low systemic and local toxicity and are generally well tolerated, although a rare individual may exhibit hypersensitivity, such as contact dermatitis. It may produce skin irritation in some individuals; chemical burns and severe vaginal irritation may occur if administered in an occlusive dressing, casts, or in anal or vaginal packs; directions for dilution and administration should be carefully followed. In preoperative antisepsis of the skin, the solutions should not be permitted to remain in prolonged contact with the patient's skin; avoid pooling of the solution on the operating table. The topical cold sore product may produce a brief stinging sensation upon use.
Antiseptics such as benzalkonium chloride solutions must not be relied upon to achieve complete sterilization, because they do not destroy bacterial spores and certain viruses, including the etiologic agent of infectious hepatitis, and may not destroy Mycobacterium tuberculosis and other rare bacterial strains.
The use of benzalkonium chloride in an occlusive dressing, casts, and anal or vaginal packs is not recommended as this may produce irritation or chemical burns.
The safety and efficacy of benzalkonium chloride aqueous solution in neonates has not been established. The safety and efficacy of the topical gel have not been established in neonates, infants, children, or adolescents. The safety and efficacy of the topical foam has not been established in children less than 2 years of age.
The manufacturers of benzalkonium chloride do not give specific information regarding FDA pregnancy risk category; however, use in obstetrics and gynecology is very common and use is listed in the perioperative indications for the topical solutions. Care should be taken to follow recommended dilutions and administration directions. When administered topically, systemic exposure is likely limited. Compared to iodophor agents such as povidone-iodine, which may cause safety issues during perinatal use , chlorhexidene and benzalkonium chloride are proposed as alternate antiseptic agents due to less systemic exposure.
The manufacturers of benzalkonium chloride do not give specific information regarding the use of these products while breast-feeding; however, use in obstetrics or gynecology is very common and use is listed in the perioperative indications for the topical solutions. Topical use is not likely to result in significant systemic absorption; dilution and application techniques should be carefully followed. Use of these topical products on the breast during nursing should/would likely be avoided. Compared to iodophor agents such as povidone-iodine, which may cause safety issues during perinatal use, including concerns in breast-feeding neonates , chlorhexidene and benzalkonium chloride are proposed as alternate antiseptic agents due to less systemic exposure. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Topical exposure to benzalkonium chloride have low systemic and local toxicity and are generally well tolerated. If accidental exposure to benzalkonium chloride solution, particularly a concentrated solution occurs, systemic toxicity is possible. If ingested, marked local irritation of the gastrointestinal tract, manifested by nausea and vomiting, may occur. Signs of systemic toxicity include restlessness, apprehension, weakness, confusion, dyspnea, cyanosis, collapse, convulsions, and coma. The manufacturer recommends certain treatment practices, and the consultation of emergency health care professionals, in the case of accidental oral ingestion. If unintended ocular exposure occurs, especially if solutions stronger than 1:3000 enter the eyes, irrigate immediately and repeatedly with water. Prompt medical attention should then be obtained.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Escherichia coli, Salmonella enterica serotype Typhi , Staphylococcus aureus (MRSA), Staphylococcus aureus (MSSA), Streptococcus pyogenes (group A beta-hemolytic streptococci)
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For the use as skin antisepsis including antisepsis of the skin, mucous membranes, and wounds; for pre-operative preparation of the skin and surgeons' hand and arm soaks; treatment of wounds; and preservation of irrigations of the eye, body cavities, urologic irrigation (bladder, urethra), and vaginal douching:
Topical, Ophthalmic, Urethral, Vaginal, and Intracavitary Dosage:
Adults: Recommended dilutions for use vary between 1:750 and 1:40,000, depending on area of application and reason for usage.
Infants, Children, and Adolescents: Recommended dilutions for use vary between 1:750 and 1:40,000, depending on area of application and reason for usage.
For the treatment of cold sores / fever blisters (herpes labialis):
NOTE: The OTC use of benzalkonium chloride cold sore tincture has not been evaluated by the FDA for safety and efficacy in the treatment of herpes labialis.
Topical Dosage:
Adults, Adolescents, and Children > 2 years: Apply to affected area no more than 3 times per day. Usually 1 treatment is sufficient. Do not use for more than 1 week unless directed by a physician.
Neonates, Infants, and Children younger than 2 years: Safety and efficacy have not been established. Consult a physician.
For wound management of first and second degree burns, lacerations, skin abrasion, and skin tears:
Topical Dosage (Topical gel):
Adults: Evenly apply approximately one-eighth inch to one-fourth inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.
Topical Dosage (Topical solution):
Adults: Recommended dilutions for use vary between 1:750 and 1:40,000, depending on area of application and reason for usage.
Infants, Children, and Adolescents: Recommended dilutions for use vary between 1:750 and 1:40,000, depending on area of application and reason for usage.
Topical Dosage (Topical foam):
Adults: Clean the affected area by applying a small amount of foam and wiping away any dirt or debris with a sterile gauze. After the affected area is clean, apply a small amount of foam 1 to 3 times daily. With each application, allow the foam to dissipate into the wound and wipe away any excess with a sterile gauze. The foam should be allowed to dry before covering the wound with a sterile bandage.
Children and Adolescents 2 to 17 years: Clean the affected area by applying a small amount of foam and wiping away any dirt or debris with a sterile gauze. After the affected area is clean, apply a small amount of foam 1 to 3 times daily. With each application, allow the foam to dissipate into the wound and wipe away any excess with a sterile gauze. The foam should be allowed to dry before covering the wound with a sterile bandage.
-for wound management of stasis ulcers, pressure ulcers, diabetic ulcers, surgical incision sites, device insertion sites, graft sites, and donor sites:
Topical Dosage (Topical gel):
Adults: Evenly apply approximately one-eighth inch to one-fourth inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.
Topical Dosage (Topical solution):
Adults: Recommended dilutions for use vary between 1:750 and 1:40,000, depending on area of application and reason for usage.
Infants, Children, and Adolescents: Recommended dilutions for use vary between 1:750 and 1:40,000, depending on area of application and reason for usage.
Maximum Dosage Limits:
-Adults
Maximum dosage not established; do not exceed recommended dilutions.
-Geriatric
Maximum dosage not established; do not exceed recommended dilutions.
-Adolescents
Maximum dosage not established; do not exceed recommended dilutions.
-Children
Maximum dosage not established; do not exceed recommended dilutions.
-Infants
Maximum dosage not established; do not exceed recommended dilutions.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Aluminum Acetate, Burow's Solution: (Moderate) The use of topical aluminum products (aluminum acetate, Burow's solution or aluminum chloride) with benzalkonium chloride aqueous solutions may be incompatible.
Fluorescein: (Moderate) The use of fluorescein with benzalkonium chloride aqueous solutions may be incompatible.
Hylan G-F 20: (Major) Do not use concomitant disinfectants that contain quaternary ammonium salts (e.g., benzalkonium chloride) for skin preparation prior to hylan G-F 20 intra-articular injection, as hyaluronan can precipitate in the presence of these disinfectants.
Minocycline: (Major) Sodium chloride (saline solutions) should not be used to dilute benzalkonium chloride as saline solutions may decrease the antibacterial potency of the antiseptic. Stored tap water should also not be used for dilution since it may contain microorganisms. Resin deionized water may also contain pathogens and it may inactivate benzalkonium chloride.
Povidone-Iodine: (Moderate) The use of iodine (iodine; potassium iodide, KI or povidone-iodine) with benzalkonium chloride aqueous solutions may be incompatible.
Pyrethrins; Piperonyl Butoxide: (Major) Sodium chloride (saline solutions) should not be used to dilute benzalkonium chloride as saline solutions may decrease the antibacterial potency of the antiseptic. Stored tap water should also not be used for dilution since it may contain microorganisms. Resin deionized water may also contain pathogens and it may inactivate benzalkonium chloride.
Silver Nitrate: (Moderate) The use of silver nitrate with benzalkonium chloride aqueous solutions may be incompatible.
Sodium Chloride: (Major) Sodium chloride (saline solutions) should not be used to dilute benzalkonium chloride as saline solutions may decrease the antibacterial potency of the antiseptic. Stored tap water should also not be used for dilution since it may contain microorganisms. Resin deionized water may also contain pathogens and it may inactivate benzalkonium chloride.
Sulfacetamide; Sulfur: (Major) Sodium chloride (saline solutions) should not be used to dilute benzalkonium chloride as saline solutions may decrease the antibacterial potency of the antiseptic. Stored tap water should also not be used for dilution since it may contain microorganisms. Resin deionized water may also contain pathogens and it may inactivate benzalkonium chloride.
Benzalkonium chloride (BAK) solutions are rapidly acting, cationic, surface-active anti-infective agents with a moderately long duration of action. They are active against bacteria, some viruses, fungi, and protozoa; however, bacterial spores, certain viruses (hepatitis viruses), and potentially Mycobacterium tuberculosis are resistant to BAK. Solutions may be bacteriostatic or bactericidal depending on their concentrations. The exact mechanism of bactericidal action is not known; however, activity may be due to enzyme inactivation. Activity increases with increasing temperature and pH. In general, gram-positive bacteria are more susceptible than gram-negative bacteria. When benzalkonium chloride solutions are applied by friction (using several changes of sponges), dirt, skin fats, desquamating epithelium, and superficial bacteria are removed, thus exposing the underlying skin to the antiseptic activity of the BAK solution.
An aqueous solution of benzalkonium chloride 1:750 has been shown to retain its bactericidal activity after autoclaving for 30 minutes at 15 lb pressure, freezing, and then thawing. To maintain antiseptic action, the BAK solutions must be prepared and stored correctly; serious inactivation and contamination may occur with misuse.
Benzalkonium chloride is applied topically, used in ophthalmic solutions as a preservative in small amounts, or may be administered as an irrigation. Pharmacokinetic information is limited. These cationic, quaternary topical solutions usually do not exhibit significant systemic absorption or toxicity.