PERMETHRIN

Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% is for topical use only. Chemical Name – The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2, 2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C 21 H 20 Cl 2 O 3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid. Active Ingredient – Each gram contains permethrin 50 mg (5%). Inactive Ingredients – Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.

Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

Adults and children – Thoroughly massage Permethrin Cream, 5% into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE . Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

Permethrin Cream, 5% is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

In clinical trials, generally mild and transient burning and stinging followed application with permethrin cream, 5% in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS-General ). Other adverse events reported since marketing permethrin cream, 5% include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream, 5% treatment.

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Padagis Yeruham, Israel Distributed By Padagis Allegan, MI 49010 www.padagis.com Rev 01-23 77L00 RC PH1