Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Permethrin Cream 5% (wt./wt.) is supplied in 60 g tubes. Store at room temperature 15°-25°C (59°-77°F). Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 12/2019; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Actavis NDC 0472-0242-60 Permethrin Cream 5% w/w Rx Only For External Use Only Not For Use In Eyes 60g (2.2 oz) 1
- HOW SUPPLIED Permethrin Cream 5% (wt./wt.) is supplied in 60 g tubes. Store at room temperature 15°-25°C (59°-77°F). Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 12/2019
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Actavis NDC 0472-0242-60 Permethrin Cream 5% w/w Rx Only For External Use Only Not For Use In Eyes 60g (2.2 oz) 1
Overview
Permethrin Cream 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in a white to off-white, vanishing cream base. Permethrin cream is for topical use only. Structural Formula: 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. Each gram contains permethrin 50 mg (5%) and the inactive ingredients butylated hydroxytoluene, carbomer 934P, coconut oil, glycerin, glyceryl stearate, isopropyl myristate, lanolin alcohols, light mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0 . 1%) is added as a preservative. fc7b7123-figure-01
Indications & Usage
Permethrin cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).
Dosage & Administration
Adults and children: Thoroughly massage permethrin cream 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.
Warnings & Precautions
WARNINGS If hypersensitivity to permethrin cream occurs, discontinue use.
Contraindications
Permethrin cream 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 in 10% of patients and was associated with the severity of infestation. Pruritis 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 ).
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