benzyl alcohol

Benzyl alcohol is a component of creams and ointments applied topically to relieve pain from cold (canker) sores or blisters in the mouth and gum irritations, and to treat head lice infestation (pediculosis).

Benzyl alcohol oral topical formulations are available over the counter (OTC) in the U.S., however, the lotion used to treat head lice infestation has been discontinued and is no longer available.

Benzyl alcohol is an aromatic compound that has antiseptic and anesthetic properties. Benzyl alcohol gel and ointment, when applied on the canker sores or gums, dries out and forms a protective antiseptic film while also acting as a local anesthetic. Benzyl alcohol lotion, when applied to the scalp and hair, gets into the respiratory openings (spiracles) of the lice and suffocates the lice, killing them, however, it has no effect on the lice eggs (nits).

In addition to topical applications for pain relief, benzyl alcohol is also used as a preservative in pharmaceutical and cosmetic preparations, solubilizing agent, and as a component of disinfectant solutions. It is added as a local anesthetic to injections to reduce pain at the injection site and is also used to periodically flush intravascular catheters to prevent infection.

In adults, benzyl alcohol is quickly metabolized into benzoic acid by the liver, which is then converted to hippuric acid and eliminated in the urine. In newborn children, particularly preterm babies, the liver is not fully mature and does not produce adequate enzymes required to metabolize benzyl alcohol, leading to its accumulation. The accumulation of benzyl alcohol and its metabolite benzoic acid is toxic and can lead to “gasping syndrome” in neonates, a condition with excessive acidity of body fluids (metabolic acidosis) that can be fatal.

• Do not use OTC benzyl alcohol preparations if you are hypersensitive to any of the components in the formulation.
• Do not use benzyl alcohol in neonates, it can cause gasping syndrome, a condition that leads to metabolic acidosis with respiratory distress, gasping respirations, central nervous system (CNS) dysfunction (including convulsions and intracranial hemorrhage), low blood pressure (hypotension), and cardiovascular collapse.
• Do not use OTC benzyl alcohol oral gel in children below 2 years, use with caution in older children.
• Benzyl alcohol oral ointment is not intended for use in children.
• Do not use benzyl alcohol lotion for head lice in children below 6 months, use with caution in older children.
• Benzyl alcohol may cause contact dermatitis, discontinue if you develop symptoms.

Common side effects of benzyl alcohol include:

• Itching (pruritus)
• Redness (erythema)
• Application site reactions such as:
  • Pain
  • Irritation
  • Reduced sensation (hypoesthesia)
  • Loss of sensation (anesthesia)
• Eye irritation
• Dry skin (xeroderma)
• Skin rash
• Skin peeling (desquamation)
• Skin picking (excoriation)
• Tingling and numbness (paresthesia)
• Dermatitis
• Seborrheic dermatitis of scalp
• Burn (thermal) injury

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Gel, Mouth/Throat

• Zilactin: 10% (7.1 g)

Lotion, External:

• Ulesfia: 5% (227 g)

Ointment, Mouth/Throat (Only Adults)

• AverTeaX: 1% (7.4 mL)

Cold Sores/Fever Blisters/Oral Pain

Adults and children 2 years or older

• Gel: Apply to affected area up to 4 times daily; do not use for longer than 7 days in pediatric patients

Adults

• Ointment: Apply to affected area as needed

Head lice

Adults and children above 6 months

• Topical lotion: Apply appropriate volume for hair length to dry hair and completely saturate the scalp; leave on for 10 minutes; rinse thoroughly with water; repeat in 7 days.

Administration

• Gel: Dry affected area and apply only with moistened cotton swab or clean finger. Allow to dry 30 to 60 seconds. Do not peel off protective film; to remove film, first apply another coat of benzyl alcohol to film, and immediately wipe the area with a moist gauze pad or tissue.
• Lotion: Apply to dry hair until completely saturated. Leave on for 10 minutes, followed by a thorough water rinse. Avoid contact with eyes. Wash hands after application. Use in conjunction with an overall lice management program. Dry clean or wash all clothing, hats, bedding, and towels in hot water. Wash all personal care items (e.g., combs, brushes, hair clips) in hot water. May use a fine-tooth or special nit comb to remove nits and dead lice.
• Ointment (Only adults): For best results, apply at the first sign of symptoms (e.g., itching, redness, tightness, tingling).

• Overdose of benzyl alcohol in adults can cause irritation, allergic contact dermatitis, and central nervous system depression leading to hypotension, convulsion, paralysis, and respiratory failure.
• The minimum amount that is toxic to newborn infants is not known. Because the livers of newborns are not fully developed, any exposure to benzyl alcohol and its metabolites can lead to gasping syndrome, with metabolic acidosis, and liver and kidney damage.
• Treatment for benzyl alcohol toxicity is primarily discontinuation of exposure and supportive care. Hemodialysis may help eliminate benzyl alcohol and its metabolites and may also be useful in correcting severe metabolic acidosis.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Benzyl alcohol has no known severe, serious, moderate, or mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate well controlled studies on use of benzyl alcohol in pregnant or breastfeeding women, however, topical benzyl alcohol use is likely safe for use during pregnancy and nursing.
• Minimal systemic absorption is expected to result when benzyl alcohol is applied topically as prescribed. Use of topical benzyl alcohol by a pregnant or breastfeeding woman is not expected to result in exposure to the fetus or the breastfed infant.

• Use OTC benzyl alcohol products exactly as directed on the label. Do not use larger amounts or for longer periods than recommended.
• Avoid exposure to the eye, and flush the eye thoroughly if accidental exposure occurs.
• Do not use benzyl alcohol for longer than 7 days unless instructed by your doctor.
• If you self-medicate with OTC benzyl alcohol, discontinue and notify your physician if:
  • Your condition worsens or does not improve within 7 days
  • You develop swelling, rash, or fever
• Store safely out of reach of children. Pediatric use should be under adult supervision.
• In case of overdose, seek medical help or contact Poison Control.