benzyl alcohol (OTC)

Frequency Not Defined

Application site irritation

Dryness

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

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.

Mechanism of Action

Elicits drying effect on cold sores