Ulesfia

Ectoparasiticides, Including Scabicides

Application of Ulesfia (benzyl alcohol) topical lotion:
Benzyl alcohol lotion is administered topically to the scalp. It is not for oral, ophthalmic, or intravaginal use.
Cover the face and eyes of the child or patient with a towel and keep their eyes closed tightly.
Apply lotion directly to dry hair. Lotion must cover the entire scalp and all scalp hair. An adult should apply the lotion to a child or other patient needing assistance.
Massage the lotion into the hair and scalp. When the head is completely covered with enough lotion, dripping will happen. Protect the eyes and skin from these drips with the towel.
Be sure to apply lotion to the area behind the ears.
Be sure to apply lotion to the back of the neck.
If not enough lotion is used, some lice may escape treatment. It is important to use the full amount of lotion prescribed.
Allow lotion to stay on the hair for 10 minutes. Use a timer or clock. Start timing after completely covering the hair and scalp with lotion.
After 10 minutes, completely rinse lotion from hair and scalp with water.
Wash your hands after application.
Hair may be shampooed right after the treatment.
One week (7 days) after the first treatment, repeat the steps above to help get rid of lice that hatched from eggs.
A lice comb may be used to remove the dead lice after both treatments.
Use lotion in the context of an overall lice management program: wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels, wash personal care items such as combs, brushes and hair clips in hot water. A fine-tooth comb or special nit comb may be used to remove dead lice and nits.

erythema / Early / 7.0-10.0
hyperesthesia / Delayed / 1.0-1.0
contact dermatitis / Delayed / 0.1-1.0

pruritus / Rapid / 12.0-12.0
ocular irritation / Rapid / 6.0-6.0
skin irritation / Early / 2.0-2.0
hypoesthesia / Delayed / 2.0-2.0
xerosis / Delayed / 0.1-1.0
paresthesias / Delayed / 0.1-1.0
rash / Early / 0.1-1.0

Ulesfia

Rx

Benzyl alcohol lotion is a topical pediculicide.
Used for the treatment of pediculosis capitis (i.e., head lice).
Amount of lotion to use depends on hair length; always repeat treatment in 7 days.

NOTE: The amount of lotion that should be used for each treatment is determined by the length of hair to be treated.

Apply 4 to 6 ounces (one-half to three-quarters bottle) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 6 to 8 ounces (three-quarters to 1 bottle) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 8 to 12 ounces (1 to 1.5 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 12 to 24 ounces (1.5 to 3 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 24 to 32 ounces (3 to 4 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 32 to 48 ounces (4 to 6 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 4 to 6 ounces (one-half to three-quarters bottle) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 6 to 8 ounces (three-quarters to 1 bottle) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 8 to 12 ounces (1 to 1.5 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 12 to 24 ounces (1.5 to 3 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 24 to 32 ounces (3 to 4 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Apply 32 to 48 ounces (4 to 6 bottles) of lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat after 7 days.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Benzyl Alcohol products.

Ulesfia Topical Lotion: 5%

60 years and younger: 1 application per week.
older than 60 years: Safety has not been established.

Safety has not been established.

1 application per week.

1 application per week.

6 months and older: 1 application per week.
younger than 6 months: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Benzyl alcohol inhibits lice from closing their respiratory spiracles, which results in obstruction of the spiracles by the vehicle and subsequent asphyxiation of the lice. Benzyl alcohol does not have ovicidal activity.

Benzyl alcohol is administered topically to the hair and scalp. The metabolism and excretion of locally applied benzyl alcohol is unknown.

The topical absorption of benzyl alcohol was studied in nineteen pediatric subjects with head lice infestation. The subjects were divided into 2 age groups: 6 months to 3 years, and 4 to 11 years. Quantifiable amounts of benzyl alcohol were found in the plasma of 4 patients after topical application of benzyl alcohol lotion for an exposure period 3 times greater than the normal exposure period. Of 102 analyzed samples, three subjects in the younger age group had plasma concentrations ranging from 1.97 to 2.99 mcg/mL one-half hour after treatment and one subject in the older age group had a plasma concentration of 1.63 mcg/mL 1 hour after treatment.

Data regarding the use of benzyl alcohol topical lotion during human pregnancy are insufficient to establish a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. However, 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 drug exposure. In animal studies, subcutaneous administration of benzyl alcohol to pregnant rats and rabbits during organogenesis did not result in any fetal malformations but was associated with decreased fetal weight.[35400]

There are no data regarding the excretion of benzyl alcohol in human milk, the effects of the drug on a breast-fed infant, or the effects on milk production. When administered topically, benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, breast-feeding is not expected to result in infant drug exposure. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.