Permethrin PERMETHRIN 5% W W A-S MEDICATION SOLUTIONS FDA Approved Permethrin Cream 5% w/w is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream 5% w/w 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 - Carbomer homopolymer type B, medium-chain triglycerides, glycerin, mono-and diglycerides, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene (20) cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative. structure.jpg
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Substance Permethrin
Route
TOPICAL
Applications
ANDA211303
Product NDC
Package NDC

Drug Facts

Composition & Profile

Strengths
60 g
Quantities
0 count
Treats Conditions
Indications And Usage Permethrin Cream 5 W W Is Indicated For The Treatment Of Infestation With Sarcoptesscabiei Scabies

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
509F88P9SZ
Packaging

HOW SUPPLIED Product: 50090-5888 NDC: 50090-5888-0 60 g in a TUBE / 1 in a CARTON; PERMETHRIN Label Image

Package Descriptions
  • HOW SUPPLIED Product: 50090-5888 NDC: 50090-5888-0 60 g in a TUBE / 1 in a CARTON
  • PERMETHRIN Label Image

Overview

Permethrin Cream 5% w/w is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream 5% w/w 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 - Carbomer homopolymer type B, medium-chain triglycerides, glycerin, mono-and diglycerides, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene (20) cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative. structure.jpg

Indications & Usage

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

Dosage & 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.

Warnings & Precautions
WARNINGS If hypersensitivity to Permethrin Cream 5% w/w occurs, discontinue use.
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% w/w 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% w/w 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% w/w treatment.


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