Permethrin

INDICATIONS AND USAGE Permethrin Cream 5% w/w is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).

DOSAGE AND ADMINISTRATION Adults and children - Thoroughly massage Permethrin Cream 5% w/w 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.

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

ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DESCRIPTION: Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, greaseless, uniform mass. 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 CI 2 O 3 and a molecular weight of 391.29. It is a colorless or slightly brownish viscous liquid, semi-solid or crystalline solid. Active Ingredient - Each gram contains permethrin 50 mg (5%). Inactive Ingredients - Butylated hydroxytoluene, carbomer homopolymer type B, ceteth-2, ceteth-20, glycerin, isopropyl myristate, lanolin alcohols, medium chain triglycerides, mineral oil, mono and di-glycerides, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative. Chemical Structure

OVERDOSAGE No instance of accidental ingestion of Permethrin Cream 5% w/w has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION ) may result in increased irritation and erythema.

HOW SUPPLIED Permethrin Cream 5% w/w is available as follows: 60 g tube 68788-8439-6 STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa – 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713 USA Rev 04 May 2025 Relabeled By: Preferred Pharmaceuticals Inc.