Elimite label

Elimite

Elimite Recall

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Side Effects & Adverse Reactions

If hypersensitivity to ELIMITE™ (permethrin) 5% Cream occurs, discontinue use.

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.

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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.

Elimite Manufacturers

  • Prestium Pharma, Inc.
    Elimite | Prestium Pharma, Inc.
    No Recall

    Elimite | 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.