Version May 2024
Note: Ulesfia lotion has been discontinued in the United States for >1 year.
Head lice: Infants ≥6 months, Children, and Adolescents: Lotion (Ulesfia): Apply appropriate volume for hair length to dry hair, saturate the scalp completely, leave on for 10 minutes, rinse thoroughly with water; repeat in 7 days.
Hair length 0 to 2 inches: 4 to 6 ounces.
Hair length 2 to 4 inches: 6 to 8 ounces.
Hair length 4 to 8 inches: 8 to 12 ounces.
Hair length 8 to 16 inches: 12 to 24 ounces.
Hair length 16 to 22 inches: 24 to 32 ounces.
Hair length >22 inches: 32 to 48 ounces.
Oral pain: Children ≥2 years and Adolescents: Topical: Gel (Zilactin): Apply to affected area up to 4 times/day; do not use for more than 7 days.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Benzyl alcohol: Drug information")
Note: Ulesfia lotion has been discontinued in the United States for >1 year.
Head lice: 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.
Hair length 0 to 2 inches: 4 to 6 ounces.
Hair length 2 to 4 inches: 6 to 8 ounces.
Hair length 4 to 8 inches: 8 to 12 ounces.
Hair length 8 to 16 inches: 12 to 24 ounces.
Hair length 16 to 22 inches: 24 to 32 ounces.
Hair length >22 inches: 32 to 48 ounces.
Oral pain: Topical:
Gel: Apply to affected area up to 4 times daily.
Ointment: Apply to affected area as needed.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Dermatologic: Pruritus (12%), erythema (10%)
1% to 10%:
Central nervous system: Local anesthesia (2%), hypoesthesia (2%; local)
Local: Local irritation (2%), local pain (1%)
Ophthalmic: Eye irritation (6%)
<1%, postmarketing, and/or case reports: Dermatitis, desquamation, excoriation, paresthesia, seborrheic dermatitis of scalp, skin rash, thermal injury, xeroderma
There are no contraindications listed in the manufacturer's labeling.
OTC labeling: When used for self-medication, do not use if allergic to benzyl alcohol or any component of the formulation.
Concerns related to adverse effects:
• Contact dermatitis: Allergic or irritant dermatitis may occur.
• Eye irritation: Avoid eye exposure. If eye is exposed, flush immediately with water.
Special populations:
• Children: Use under direct adult supervision. Keep out of children's reach. Lotion for the treatment of head lice is not recommended for infants <6 months due to the potential for increased absorption. Do not use gel for oral pain in infants or children younger than 2 years.
• Neonates: Intravenous administration of benzyl alcohol-containing products has been associated with a neonatal gasping syndrome. Patients <1 month of age or premature neonates with a corrected gestational age <44 weeks could be at risk if treated with topical benzyl alcohol.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Self-medication (OTC use): Discontinue use and notify health care provider if condition worsens or does not improve within 7 days, or if swelling, rash, or fever develops. Do not use for >7 days unless instructed by health care professional.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Ulesfia lotion has been discontinued in the United States for >1 year.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Gel, Mouth/Throat:
Zilactin: 10% (7.1 g) [contains propylene glycol, sd alcohol]
Lotion, External:
Ulesfia: 5% (227 g [DSC]) [contains polysorbate 80, trolamine (triethanolamine)]
Ointment, Mouth/Throat:
AverTeaX: 1% (7.4 mL) [contains cetyl alcohol, propylene glycol, trolamine (triethanolamine)]
No
Gel (Zilactin Mouth/Throat)
10% (per gram): $0.70
Ointment (AverTeaX Mouth/Throat)
1% (per mL): $1.35
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For external topical use only; avoid contact with eyes. Do not swallow.
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 under adult supervision to dry hair, until entire scalp and hair are saturated. Leave on for 10 minutes then rinse thoroughly. 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 (eg, combs, brushes, hair clips) in hot water. A lice comb may be used to remove dead lice after both treatments.
For topical use only.
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 (eg, combs, brushes, hair clips) in hot water. May use a fine-tooth or special nit comb to remove nits and dead lice.
Ointment: For best results, apply at the first sign of symptoms (eg, itching, redness, tightness, tingling).
Gel: Store at 15°C to 30°C (59°F to 68°F). Keep away from fire or flame.
Lotion: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not freeze.
Dermal topical: Lotion (Ulesfia): Treatment of head lice infestation (FDA approved in ages ≥6 months and adults)
Oral topical:
Gel (Zilactin): Temporary relief of pain from cold sores/fever blisters, canker sores, mouth sores, and/or gum irritations (FDA approved in ages ≥2 years and adults)
Cream (AverTeaX): Temporary relief of pain caused by cold sores/fever blisters (FDA approved in adults)
Benzyl alcohol may be confused with benzoyl peroxide
None known.
There are no known significant interactions.
Only minimal systemic absorption is expected when benzyl alcohol is used topically as indicated (Koch 2016).
Inhibits respiration of lice by obstructing respiratory spiracles causing lice asphyxiation. No ovicidal activity.
Absorption: Lotion: Following a prolonged application (30 minutes), serum concentrations were detectable (≤3 mcg/mL) at 30 and 60 minutes postexposure in patients 6 months to 11 years of age.
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