Label: ELIMITE- permethrin cream

(PERMETHRIN) 5%* *W/W

Rx only

ELIMITE® (permethrin) 5% Cream is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, greaseless, uniform mass. 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 C21H20CI2O3 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.

Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.

Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14C-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

ELIMITE® (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

ELIMITE® (permethrin) 5% Cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

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

In clinical trials, generally mild and transient burning and stinging followed application with ELIMITE® (permethrin) 5% Cream 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 ELIMITE® (permethrin) 5% Cream 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 ELIMITE® treatment.

No instance of accidental ingestion of ELIMITE® (permethrin) 5% Cream 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.

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.

ELIMITE® Cream, 5% contains 50 mg permethrin per gram. The off-white, greaseless, uniform mass is available as follows:

Carton containing one 60 g tube                                 NDC 59651-834-60

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature.]

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 11/2023

NDC 59651-834-60

Rx only

ELIMITE® CREAM
(PERMETHRIN)
5%*

*W/W
FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.

AUROBINDO                                    60 g

NDC 59651-834-60

Rx only

ELIMITE® CREAM
(PERMETHRIN)
5%*

*W/W
FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.

AUROBINDO                                    60 g