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Benzyl alcohol: Drug information

Benzyl alcohol: Drug information
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For additional information see "Benzyl alcohol: Patient drug information" and "Benzyl alcohol: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • AverTeaX [OTC];
  • Zilactin [OTC]
Pharmacologic Category
  • Analgesic, Topical;
  • Topical Skin Product
Dosing: Adult
Oral pain

Oral pain: Topical:

Gel: Apply to affected area up to 4 times daily.

Ointment: Apply to affected area as needed.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Benzyl alcohol: Pediatric drug information")

Oral pain

Oral pain: Children ≥2 years and Adolescents: Topical: Gel 10% (Zilactin): Apply to affected area up to 4 times/day; do not use for more than 7 days.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Contraindications

OTC labeling: When used for self-medication, do not use if allergic to benzyl alcohol or any component of the formulation.

Warnings/Precautions

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. 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.

Warnings: Additional Pediatric Considerations

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).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, Mouth/Throat:

Zilactin: 10% (7.1 g) [contains propylene glycol, sd alcohol]

Ointment, Mouth/Throat:

AverTeaX: 1% (7.4 mL) [contains cetyl alcohol, propylene glycol, trolamine (triethanolamine)]

Generic Equivalent Available: US

No

Pricing: US

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.

Administration: Adult

Topical: 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.

Ointment: For best results, apply at the first sign of symptoms (eg, itching, redness, tightness, tingling).

Administration: Pediatric

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.

Use: Labeled Indications

Oral pain:

Gel: Temporary relief of pain from cold sores/fever blisters, canker sores, mouth sores, and/or gum irritations in patients 2 years and older.

Ointment: Temporary relief of pain and itching associated with fever blisters and cold sores.

Medication Safety Issues
Sound-alike/look-alike issues:

Benzyl alcohol may be confused with benzoyl peroxide

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Only minimal systemic absorption is expected when benzyl alcohol is used topically as indicated (Koch 2016).

Breastfeeding Considerations

It is unknown if benzyl alcohol is present in breast milk.

Only minimal systemic absorption is expected when benzyl alcohol is used topically as indicated (Koch 2016).

Mechanism of Action

Inhibits respiration of lice by obstructing respiratory spiracles causing lice asphyxiation. No ovicidal activity.

  1. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  2. Averteax (benzyl alcohol) [prescribing information]. Augusta, GA: Carmellix, LLC; received March 2017.
  3. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  4. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  5. Koch E, Clark JM, Cohen B, et al. Management of head louse infestations in the United States—a literature review. Pediatr Dermatol. 2016;33(5):466‐472. doi:10.1111/pde.12982 [PubMed 27595869]
  6. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  7. Zilactin (benzyl alcohol gel) [prescribing information]. Columbus, IN: Blairex Laboratories Inc; November 2021.
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