Ulesfia

Benzyl alcohol lotion may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• itching of the scalp area
• redness of the scalp area
• numbness or pain in the scalp area

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• irritation of the scalp area
• infected or pus filled areas of skin in the scalp area

Benzyl alcohol lotion may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Pregnancy Category: B

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Apply the full amount of Ulesfia prescribed by your healthcare provider for each of your 2 applications one week apart. Your doctor will prescribe a specific amount of Ulesfia based on your hair length. Be sure to cover all of your scalp area and hair.

Ulesfia gets rid of lice but does not get rid of lice eggs so a second application is needed one week (7 days) after the first application.

• Use Ulesfia exactly as prescribed. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
• Use Ulesfia in two applications that are one week apart. Ulesfia Lotion gets rid of lice but does not get rid of lice eggs so a second application is needed one week (7 days) after the first application.
• Ulesfia coats the lice on your scalp and scalp hair. It is important to use enough Ulesfia to coat completely every single louse and to leave it on your scalp for the full 10 minutes. 
• Because you need to completely cover all of the lice with Ulesfia, you may need help in applying Ulesfia to your scalp and hair. Make sure that you and anyone who helps you apply Ulesfia reads and understands the instructions for use.
• Children need adult help in applying Ulesfia.
• Do not get into eyes. If Ulesfia gets in the eye, flush with water right away.
• Do not swallow Ulesfia. If swallowed, call your healthcare provider right away.
• Wash your hands after you apply Ulesfia.

• Store Ulesfia in a dry place at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze Ulesfia.
• Keep Ulesfia and all medicines out of the reach of children.

To help prevent the spread of lice from one person to another, here are some steps you can take.

• Avoid head-to-head contact at school, on the playground, in physical education classes, during sports activities, and while playing with other children.
• Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
• Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.
• After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
• Machine-wash any bedding and clothing used by anyone having lice or thought to have been exposed to lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.

Pediculosis

Topical treatment of pediculosis capitis (head lice infestation) in adults and pediatric patients ≥6 months of age.1 2

AAP usually recommends topical permethrin 1% or topical pyrethrins with piperonyl butoxide for initial treatment;3 these experts state benzyl alcohol 5% may be considered for patients ≥6 months of age in geographic areas with known resistance to permethrin or pyrethrins or for a documented infestation that did not respond to permethrin or pyrethrins.3

Contraindications

• No known contraindications.1

Warnings/Precautions

Neonatal Toxicity

Risk of gasping syndrome if used in neonates† (i.e., infants <1 month of age or preterm infants with corrected age <44 weeks).1

Gasping syndrome has been associated with IV administration of products containing benzyl alcohol.1 10 Syndrome consists of severe metabolic acidosis, gasping respirations, progressive hypotension, seizures, CNS depression, intraventricular hemorrhage, and death in preterm, low-birthweight infants.1 10

Systemic exposure following topical application of benzyl alcohol 5% lotion expected to be lower than that associated with gasping syndrome;1 8 however, neonates and infants <6 months of age† may be at risk of increased systemic absorption and the lower limit for toxicity is unknown.1 (See Pediatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Ocular Irritation

May cause ocular irritation; avoid contact with eyes.1

Eyes should be closed tightly and covered with a soft towel or washcloth while the lotion is applied to or washed off of scalp hair.1

If lotion comes into contact with eyes, immediately flush with water.1 Persistent irritation warrants medical evaluation.1

Sensitivity Reactions

May cause allergic or contact dermatitis.1 7 10

Delayed-type contact dermatitis and immediate sensitivity reactions (e.g., urticaria, angioedema) reported rarely in patients receiving topical products containing benzyl alcohol as a preservative.7

Local Effects

Pruritus, erythema, and pyoderma reported more frequently with benzyl alcohol 5% lotion than with lotion vehicle alone.1 2

Application site reactions (i.e., irritation, anesthesia, hypoesthesia, pain) reported.1

May cause irritant dermatitis.1 7 10 Nonimmune contact reactions (e.g., urticaria, erythema, pruritus, angioedema) reported in patients receiving products containing benzyl alcohol.7 10

Specific Populations

Category B.1

Not known whether distributed into milk after topical application.1 Use with caution in nursing women.1

Safety and efficacy not established in infants <6 months of age;1 systemic absorption may be increased in this age group.1 (See Absorption under Pharmacokinetics.)Use only in infants and children ≥6 months of age.1

Neonates† may be at risk of gasping syndrome.1 (See Neonatal Toxicity under Cautions.)

Keep out of reach of children;1 use in children only under the direct supervision of an adult.1

Safety not established in patients >60 years of age.1

Common Adverse Effects

Pruritus, erythema, pyoderma, ocular irritation, application site symptoms (irritation, anesthesia, hypoesthesia).1

No formal drug interaction studies to date.1

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Ulesfia, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ulesfia. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Ulesfia (benzyl alcohol lotion).

Review Date: October 4, 2017

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

      Long-term studies in animals to evaluate carcinogenic potential of Ulesfia® Lotion have not been conducted. No evidence of carcinogenic activity was noted for benzyl alcohol in 2 year oral carcinogenicity studies in rats (doses up to 400 mg/kg benzyl alcohol) or mice (doses up to 200 mg/kg benzyl alcohol) conducted by the National Toxicology Program.

      Benzyl alcohol has produced mixed results in genetic testing. Benzyl alcohol was negative in the Ames test with and without metabolic activation, sex-linked recessive lethal assay, and a replicative DNA synthesis assay (conducted in male rats). Negative results were obtained in the mouse lymphoma assay with metabolic activation, but a positive response was noted in the mouse lymphoma assay without metabolic activation at a concentration producing a high level of cellular toxicity. Benzyl alcohol was positive in the Chinese hamster ovary chromosomal aberration assay with metabolic activation.

      No fertility studies have been conducted with benzyl alcohol. 

Get emergency medical help if you have any of these signs of an allergic reaction to Ulesfia: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If the medicine gets in your eyes or on your skin, rinse with water. Call your doctor at once if you have severe stinging, itching, or irritation of the eyes or skin after rinsing.

Common Ulesfia side effects may include mild pain, itching, irritation, redness, or numbness of your scalp.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.