Benzyl Alcohol topical

Head lice, Pediculosis capitis

Apply lotion to dry hair, using enough to completely saturate hair & scalp, rinse off with water after 10 minutes Repeat treatment in 7 days Amount of Lotion Needed to Cover Scalp and Hair Completely Hair length 0-2 inches: 4-6 ounces Hair length 2-4 inches: 6-8 ounces Hair length 4-8 inches: 8-12 ounces Hair length 8-16 inches: 12-24 ounces Hair length 16-22 inches: 24-32 ounces Hair length >22 inches: 32-48 ounces

<6 months: Do not use >6 months: Apply lotion to dry hair, using enough to completely saturate hair & scalp, rinse off with water after 10 minutes; repeat treatment in 7 days

Hypersensitivity to any of the active ingredients.

Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is used in neonates. Eye irritation: Avoid eye exposure. Flush immediately with water if Lotion comes into contact with eyes. Contact dermatitis: May occur with Lotion. Use in children: Lotion should only be used on children under the direct supervision of an adult. Keep out of reach of children.

Not Classi Pregnancy Risk Summary Rare pregnancy outcomes reported in the published literature with benzyl alcohol use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug. In animal reproduction studies, subcutaneous administration of benzyl alcohol to pregnant rats and rabbits during organogenesis did not cause any malformations. The available data do not allow the calculation of relevant comparisons between the systemic exposure of benzyl alcohol observed in animal studies to the systemic exposure that would be expected in humans after topical use of Benzyl Alcohol Lotion. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Animal Data In embryo-fetal development studies, pregnant rats and rabbits received subcutaneous doses of benzyl alcohol during organogenesis at doses up to 500 mg/kg/day and 400 mg/kg/day, respectively. There were no malformations noted in either species. In rats, maternal toxicity and decreased fetus weight occurred at 500 mg/kg/day. In rabbits, maternal toxicity occurred at 250 and 400 mg/kg/day and was associated with decreased fetal weight at 400 mg/kg/day. Lactation Risk Summary There is no information available on the presence of benzyl alcohol in human or animal milk, the effects of the drug on breastfed infant, or the effects of the drug on milk production. When used as prescribed, topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, breastfeeding is not expected to result in exposure of the infant to Benzyl Alcohol Lotion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Benzyl Alcohol Lotion and any potential adverse effects on the breastfed infant from Benzyl Alcohol Lotion or from the underlying maternal condition.

No formal drug interaction studies to date.

Generally well tolerated. However, a few allergic reactions may be seen. Irritation, itching, redness, tingling, or numbness at the application site may occur. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Asphyxiates lice by obstructing respiratory spiracles. Benzyl alcohol inhibits lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.