FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
If hypersensitivity to ELIMITE™ (permethrin) 5% Cream occurs, discontinue use.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ELIMITE™ (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).
History
There is currently no drug history available for this drug.
Other Information
ELIMITE™ (permethrin) 5% Cream is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. ELIMITE™ (permethrin) 5% Cream 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 C21H20Cl2O3 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.
Sources
Elimite Manufacturers
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Prestium Pharma, Inc.
Elimite | Prestium Pharma, Inc.
Adults and children - Thoroughly massage ELIMITE™ (permethrin) 5% 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.
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