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benzyl benzoate

P03A - Ectoparasiticides ATC P03AX01 Small molecule approved 1976 Topical Natural product

JFDA label: Benzyl Benzoate Lotion

Mechanism of Action

— Unknown

Indications

Approved

  • Head lice (lotion only)
  • Oral pain (gel only)

Contraindications

Source: Lexicomp

  • There are no contraindications listed in the manufacturer’s labeling Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Nervous system disorders (2)

Common hypoesthesia · Local anesthesia

Eye disorders (1)

Common Eye irritation

General disorders and administration site conditions (2)

Common Local irritation · local pain

Other (2)

Very Common Dermatologic: Pruritus · erythema

Dosing

Source: Lexicomp

Oral pain: Topical: Gel: Apply to affected area up to 4 times daily 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
(For additional information see "Benzyl alcohol: Pediatric drug information") Oral pain: Topical: Gel: Children ≥2 years and Adolescents: Refer to adult dosing. Head lice: Topical: Lotion: Infants ≥6 months, Children, and Adolescents: Refer to adult dosing.
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

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 • Neonates: Intravenous administration of benzyl alcohol–containing products has been associated with a neonatal gasping syndrome. Patients 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.

Pregnancy & Lactation

Pregnancy

FDA category B

Adverse events have not been observed in animal reproduction studies.

Lactation

It is unknown if benzyl alcohol is excreted in breast milk. The manufacturer recommends that caution be exercised when administering benzyl alcohol to nursing women.

Chemistry & Properties

2D structure
FormulaC14H12O2
Molecular weight212.25 g/mol
IUPAC namebenzyl benzoate
CAS120-51-4
PubChem CID2345
InChIKeySESFRYSPDFLNCH-UHFFFAOYSA-N
logP3.04 (XLogP 4.0)
Polar surface area26.3 Ų
H-bond acceptors / donors2 / 0
Drug-likeness (QED)0.73
Lipinski violations0
SMILESO=C(OCc1ccccc1)c1ccccc1

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP1A2Inhibitor
CYP2B6Inhibitor
CYP2C19Inhibitor
CYP2C8Inhibitor
CYP2C9Inhibitor

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Registered Products (4)

BrandForm / strengthPackAgentCitizen (JOD)
Benzyl Benzoate Lotion Lotion 25 % 100 ml pack varies MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.580
Scabezyl Solution 25 g/100 g 100 MILLILITER/1 BOTTLE pack varies SANA PHARMACEUTICAL INDUSTRY/JORDAN 2.750
Benzyl Benzoate Lotion Lotion 25 % 1000 ml pack varies MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 4.980
Scabezyl Solution 25 g/100 g 1000 MILLILITER/1 BOTTLE pack varies SANA PHARMACEUTICAL INDUSTRY/JORDAN 24.750