PERMETHRIN: 1,136 Adverse Event Reports & Safety Profile

DESCRIPTION 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 C 21 H 20 CI 2 O 3 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.

Chemical

Structure

INDICATIONS For the temporary relief of red, watery, or burning eyes, nasal irritation, minor sore throat, occasional headache, shortness of breath, mild abdominal pain, nausea, or vomiting due to sensitivity to or exposure to pesticides used in airline travel.*

Directions Important: Read warnings before use Adults and children 2 months old and older Inspect all household members should be checked by another person for lice and/or nits (eggs) use a magnifying glass in bright light to help you see the lice and/or nits (eggs) use a tool, such as a comb or two unsharpened pencils to lift and part the hair look for tiny nits near scalp, beginning at back of neck and behind ears small sections of hair (1-2 inches wide) should be examined at a time unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched, if either lice or nits (or eggs) are found, treat with Nix ® Creme Rinse Treat wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix ® . Rinse with water. towel dry hair so it is damp but not wet shake the bottle of Nix ® well completely saturate the hair and scalp with Nix ® . Begin to apply Nix ® behind the ears and at the back of the neck. keep Nix ® out of the eyes. Protect the eyes with a washcloth or towel. leave Nix ® on the hair for 10 minutes, but no longer rinse with warm water towel dry hair and comb out tangles if live lice are seen seven days or more after the first treatment, a second treatment should be given Remove Lice/Nits remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out. use the nit comb provided and make sure the hair remains slightly damp while removing nits if the hair dries during combing, dampen it slightly with water part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours). start at the top of the head on the section you have picked with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair. use clips to pin back each strand of hair after you have combed out the nits clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back. after combing, recheck the entire head for nits and repeat combing if necessary check the affected head daily to remove any nits that you might have missed

Directions use after shampooing with lice killing creme rinse towel dry hair apply combining gel until all the hair and scalp is thoroughly wet with product make sure product covers the area behind the ears and at the nape of the neck where there are more likely to be nits part hair into sections and clip back use the enclosed special-toothed comb to comb out dead lice and nits comb out one section at a time it is extremely important to comb out dead lice and nits if hair begins to dry, reapply additional product when you finish combing, rinse hair thoroughly with warm water.

CONTRAINDICATIONS ELIMITE ® (permethrin) 5% 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 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.

Warnings For external use only Do not use on children under 2 months of age near the eyes inside the nose, ear, mouth, or vagina on lice in eyebrows or eyelashes. See your doctor. Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic episode. When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into the eyes, immediately flush with large amounts of water scalp itching or redness may occur Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For external use only. Avoid contact with the eyes. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

PRECAUTIONS General Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with Permethrin Cream 5% w/w may temporarily exacerbate these conditions. Information for Patients Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of Permethrin Cream 5% w/w. In clinical trials, approximately 75% of patients treated with Permethrin Cream 5% w/w who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician.

Permethrin Cream

5% w/w may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if Permethrin Cream 5% w/w gets in the eyes. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Carcinogenesis, Mutagenesis, Impairment of Fertility Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies. Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study. Pregnancy: Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing

Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Pediatric Use Permethrin Cream

5% w/w is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Geriatric Use

Clinical studies of Permethrin Cream 5% w/w did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

Active ingredient (in each fluid ounce)

Permethrin

280 mg (1%)

Active ingredient: PERMETHRIN 0.25% (CAS # 52645-53-1)

Inactive ingredients balsam canada, cetyl alcohol, citric acid, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethylcellulose, polyoxyethylene 10 cetyl ether, propylene glycol, stearalkonium chloride, water, isopropyl alcohol, methylparaben, propylparaben

Ingredients water, propylene glycol, glycerin, polyquaternium-10, diazolidinyl urea, hydroxyethylcellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA [3 Control] Nix ® Lice Control Spray