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

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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.