Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)
Cerecor, Inc.
BENZYL ALCOHOL
BENZYL ALCOHOL 50 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
ULESFIA® Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. ULESFIA® Lotion does not have ovocidal activity. ULESFIA® Lotion should be used 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. None. Pregnancy Category B There are no adequate and well-controlled studies with topical benzyl alcohol in pregnant women. Reproduction studies conducted in rats and rabbits were negative. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. No comparisons of animal exposure with human exposure are provided in this labeling due to the low systemic exposure noted in t
ULESFIA® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) ● NDC 23594-780-08 as an 8 fl oz (227 g) in a polypropylene bottle ● NDC 23594-780-88 as a package containing two individual 8 fl oz (NDC 23594-780-08) polypropylene bottles with a nit comb Store at 20º C - 25º C (68º F - 77º F); excursions permitted to 15º C - 30º C (59º F - 86º F) [See USP controlled room temperature]. Do not freeze.
New Drug Application
ULESFIA- BENZYL ALCOHOL LOTION CERECOR, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ULESFIA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULESFIA . ULESFIA (BENZYL ALCOHOL) LOTION, FOR TOPICAL USE INITIAL U.S. APPROVAL: 2009 INDICATIONS AND USAGE ULESFIA Lotion is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older. (1.1) ULESFIA Lotion does not have ovocidal activity. (1.2) DOSAGE AND ADMINISTRATION Apply ULESFIA Lotion to dry hair, using enough to completely saturate the scalp and hair. (2) Rinse off with water after 10 minutes. (2) Repeat application in 7 days. (2) TABLE 1: ULESFIA LOTION USAGE GUIDE LINE Hair Length Amount of ULESFIA Lotion per Application OUNCES 8 OZ BOTTLE Short 0-2 inches 4-6 oz ½-¾ bottle 2-4 inches 6-8 oz ¾-1 bottle Medium 4-8 inches 8-12 oz 1-1½ bottles 8-16 inches 12-24 oz 1½-3 bottles Long 16-22 inches 24-32 oz 3-4 bottles Over 22 inches 32-48 oz 4-6 bottles DOSAGE FORMS AND STRENGTHS Lotion, 5% (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is used in neonates. (5.1) Eye irritation: Avoid eye exposure. Flush immediately with water if ULESFIA Lotion comes into contact with eyes. (5.2) Contact dermatitis: May occur with ULESFIA Lotion. (5.3) Use in children: ULESFIA Lotion should only be used on children under the direct supervision of an adult. Keep out of reach of children. (5.4) ADVERSE REACTIONS Most common adverse reactions (> 1% and more common than with placebo): ocular irritation, application site irritation, and application site anesthesia and hypoesthesia. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ZYLERA PHARMACEUTICALS, LLC. AT 1-866-416-9637 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Drug interaction studies were not conducted. (7) USE IN SPECIFIC POPULATIONS Pediatric Use: Safety in pediatric patients under six mo Прочитайте повний документ