benzyl alcohol (OTC)

Brand and Other Names:Zilactin Early Relief Cold Sore
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    Dosing & Uses

    AdultPediatric

    Dosage Forms & Strengths

    topical oral gel

    • 10% (Zilactin Early Relief Cold Sore)

    Cold Sores/Fever Blisters

    Apply to affected area up to q6hr

    Dosage Forms & Strengths

    topical oral gel

    • 10% (Zilactin Early Relief Cold Sore)

    Cold Sores/Fever Blisters

    <2 years: Safety and efficacy not established

    ≥2 years (Zilactin Early Relief Cold Sore): Apply to affected area up to q6hr

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    Adverse Effects

    Frequency Not Defined

    Application site irritation

    Dryness

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    Warnings

    Contraindications

    None listed by manufacturer

    Cautions

    May cause contact dermatitis

    Avoid in neonates

    Avoid eye exposure

    Gasping syndrome reported when benzyl alcohol used in neonates

    If condition does not improve within 7 days or swelling or rash develops notify healthcare provider

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    Pregnancy & Lactation

    Pregnancy

    Rare pregnancy outcomes reported in published literature with use in pregnant women are insufficient to establish drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; topical use is unlikely to be absorbed through skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to drug

    Animal data

    • In animal reproduction studies, subcutaneous administration to pregnant rats and rabbits during organogenesis did not cause any malformations; available data do not allow calculation of relevant comparisons between systemic exposure observed in animal studies to systemic exposure expected in humans after topical use

    Lactation

    There is no information available on presence agent in human or animal milk, effects of drug on breastfed infant, or on milk production; when used as prescribed, topical benzyl alcohol is unlikely to be absorbed through skin in clinically relevant amounts; therefore, breastfeeding is not expected to result in exposure of infant to drug

    Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from treatment or from the underlying maternal condition

    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.

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    Pharmacology

    Mechanism of Action

    Elicits drying effect on cold sores

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    Images

    BRAND FORM. UNIT PRICE PILL IMAGE
    Ulesfia topical
    -
    5 % lotion

    Copyright © 2010 First DataBank, Inc.

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    Patient Handout

    Patient Education
    benzyl alcohol topical

    BENZYL ALCOHOL LOTION - TOPICAL

    (BEN-zil AL-ka hol)

    COMMON BRAND NAME(S): Ulesfia

    USES: This medication is used to treat head lice, tiny insects that live on and irritate your scalp.This drug is not recommended for use in children younger than 6 months.

    HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using benzyl alcohol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is for use on the hair and scalp only. Use this medication as directed by your doctor, usually for 2 treatments, one week apart. Since this medication does not get rid of the lice eggs, it is important to have the second treatment to treat any lice that might have hatched. To help you remember, mark the date on the calendar when you need to use this medication again.An adult should help you apply this medication. Cover your eyes with a towel and keep your eyes tightly closed while the medication is being applied. The medication should be applied to dry hair and enough medication should be used to cover your entire scalp and hair (including behind the ears and on the back of the neck). Massage the medication into your hair and scalp. Avoid getting the medication in your eyes, mouth, nose, or vagina. If the medicine gets in any of these areas, flush with plenty of water. Leave the medication on your hair as directed by your doctor, usually for 10 minutes, then rinse with water. Wash your hands after using this medication. You can shampoo your hair right after treatment. A fine-tooth comb or lice comb may be used afterward to help remove the treated lice and lice eggs (nits).Tell your doctor if your condition lasts or gets worse.

    SIDE EFFECTS: Irritation, itching, redness, tingling, or numbness at the application site may occur. Eye irritation may occur if the medication gets into the eyes (see also How to Use section). If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    PRECAUTIONS: Before using benzyl alcohol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Constant or forceful scratching of the skin/scalp may lead to a bacterial skin infection. Tell your doctor right away if you develop worsening redness or pus.Children may be more sensitive to the side effects of the drug. If you are treating an infant, make sure to tell the doctor if your infant was born early (premature) so that the doctor can decide if your infant is old enough to use this medication.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

    DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

    OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    NOTES: Do not share this medication with others.To avoid spreading lice to other people or getting them again, all recently worn/used (within 2 days before treatment) head wear, scarves, clothing, towels, pillow cases, and bed linens should be machine-washed with hot water and dried in a dryer (at high setting) for at least 20 minutes. For items that cannot be washed, the items may instead be dry cleaned, sealed in a plastic bag for 2 weeks, or sprayed with a disinfectant that kills lice. Brushes, combs, and hair clips should be soaked in hot water (hotter than 130 degrees F/54 degrees C) for 10 minutes, soaked in alcohol for 1 hour, or thrown away. Furniture and floors should be thoroughly vacuumed.People who are in close contact with the infected person (such as family members in the same household) should also be checked for lice and nits. Treatment may be considered to prevent lice in these people.

    MISSED DOSE: It is important to use each dose of this medication as scheduled. If you miss the second dose, ask your doctor or pharmacist right away for further instructions.

    STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not freeze medication. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

    Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.

    IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.