{"id":"permethrin","rwe":[],"_fda":{"id":"16e69f99-ef67-4d31-8f52-e792c0d73ca8","set_id":"056fb377-34dd-4d33-83d7-c895b105f574","openfda":{"nui":["M0018228","N0000175847"],"unii":["509F88P9SZ"],"route":["TOPICAL"],"spl_id":["16e69f99-ef67-4d31-8f52-e792c0d73ca8"],"brand_name":["good sense lice killing creme rinse"],"spl_set_id":["056fb377-34dd-4d33-83d7-c895b105f574"],"package_ndc":["0113-1910-16"],"product_ndc":["0113-1910"],"generic_name":["PERMETHRIN"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Pyrethrins [CS]"],"substance_name":["PERMETHRIN"],"pharm_class_epc":["Pyrethroid [EPC]"],"manufacturer_name":["L. Perrigo Company"],"application_number":["ANDA076090"],"is_original_packager":[true]},"purpose":["Purpose Lice treatment"],"version":"2","stop_use":["Stop use and see a doctor if • breathing difficulty occurs • eye irritation occurs • skin or scalp irritation continues or infection occurs"],"warnings":["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 see 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 right away. (1-800-222-1222)"],"questions":["Questions or comments? 1-800-719-9260"],"ask_doctor":["Ask a doctor before use if you are • allergic to ragweed. May cause breathing difficulty or an asthmatic episode."],"do_not_use":["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."],"when_using":["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"],"effective_time":"20221121","active_ingredient":["Active ingredient (in each fluid ounce) Permethrin 280 mg (1%)"],"inactive_ingredient":["Inactive ingredients abies balsamea (balsam canada) extract, anhydrous citric acid, butylparaben, ceteth-10, cetyl alcohol, ethylparaben, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose, isopropyl alcohol, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearalkonium chloride"],"storage_and_handling":["Other information • read all the directions and warnings in the Consumer Information Insert before use. Keep the carton. It contains important information. • store at 20 to 25°C (68 to 77°F)"],"indications_and_usage":["Use treats head lice"],"spl_unclassified_section":["Consumer Information Permethrin Lotion, 1% Lice Treatment Creme Rinse THE FACTS OF LICE Please read all information before using Lice Treatment Creme Rinse. If you or a member of your household has head lice, don’t panic. Keep calm. Anyone can get head lice - it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems. What are head lice? • head lice are small insects that live and feed on the human scalp • they may get as big as sesame seeds and are brown • lice do not fly or jump from one person to another. They can only crawl. What are nits? • nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits. • nits are oval shaped, tiny and greyish-white • they are attached to hair with a waterproof glue-like substance that cannot be washed out or blown away Because nits (eggs) hatch in about one week, all nits must be removed to stop lice. How do head lice spread? • head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice • they may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothing How do you know if you have lice? • itching is the most common symptom • scratching behind the ears or the back of the neck is a sign that you should check for head lice • scabs or blood spots may be seen How do you prevent the spread of lice? • do not share or borrow personal items like combs, brushes, or headbands • do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animals • store hats in coat sleeves and hang coats separately, so that they do not touch other people’s hats and coats • wash under fingernails when you first see lice or nits (eggs) • check your child’s head daily when you hear of a lice outbreak in day care or school How to use the creme rinse I. Inspect If you suspect head lice - check. Head lice may be hard to locate because they avoid light. Nits are easier to see. • 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 nits (eggs) • use a tool, such as a comb or two unsharpened pencils to lift and part the hair • look for tiny nits near the scalp, beginning at the back of the neck and behind the 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 (eggs) are found, treat with the creme rinse II. 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 the creme rinse. Rinse with water. • towel dry hair so it is damp but not wet • shake the bottle well • completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck. • keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel. • leave the creme rinse 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 III. Remove Lice/Nits Treatment kills lice but does not remove the 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 IV. Clean home and personal items After using the creme rinse, it is very important to clean personal items and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about 1 day. • all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130°F), then dried in the dryer using the hottest cycle for at least 20 minutes • personal combs, including nit combs, and brushes should be soaked in hot water (above 130°F) for at least 10 minutes • personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in a plastic bag for a period of at least 4 weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again. • for anything you cannot wash, dry-clean or store in a plastic bag, spray with lice control spray. • vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members. 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 see 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 right away. (1-800-222-1222) Question or comments? 1-800-719-9260 Distributed By Perrigo® Allegan, MI 49010 :95500 00 J2 permethrin-insert-image1.jpg permethrin-insert-image2.jpg permethrin-insert-image3.jpg permethrin-insert-image4.jpg permethrin-insert-image5.jpg"],"dosage_and_administration":["Directions 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 nits (eggs) • use a tool, such as a comb or two unsharpened pencils to lift and part the hair • look for tiny nits near the scalp, beginning at the back of the neck and behind the 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 (eggs) are found, treat with the 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 the creme rinse. Rinse with water. • towel dry hair so it is damp but not wet • shake the bottle well • completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind the ears and at the back of the neck. • keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel. • leave the creme rinse 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"],"spl_product_data_elements":["good sense lice killing creme rinse Permethrin PERMETHRIN PERMETHRIN BALSAM FIR LEAFY TWIG ANHYDROUS CITRIC ACID BUTYLPARABEN CETETH-10 CETYL ALCOHOL ETHYLPARABEN FD&C YELLOW NO. 6 ISOPROPYL ALCOHOL METHYLPARABEN PHENOXYETHANOL PROPYLENE GLYCOL PROPYLPARABEN WATER STEARALKONIUM CHLORIDE"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"package_label_principal_display_panel":["Principal Display Panel Permethrin Lotion 1% Lice Treatment Lice Killing Creme Rinse With a Single Application Kills Lice & Their Eggs Prevents Reinfestation for 14 Days SAFE Approved for Use on Children Over 2 Months of Age 1 Bottle Creme Rinse & 1 Nit Removal Comb Compare to active ingredient of Nix ® Creme Rinse 100% SATISFACTION GUARANTEED 2 FL OZ (59 mL) lice killing creme rinse image"]},"tags":[{"label":"Pyrethroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"P03AC04","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Lotion","category":"form"},{"label":"Rinse","category":"form"},{"label":"Shampoo","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Infestation by Phthirus pubis","category":"indication"},{"label":"Infestation by Sarcoptes scabiei var hominis","category":"indication"},{"label":"Pediculosis Prevention","category":"indication"},{"label":"Pediculosis capitis","category":"indication"},{"label":"Pediculosis corporis","category":"indication"},{"label":"Approved 1980s","category":"decade"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Insecticides","category":"pharmacology"},{"label":"Pesticides","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"347 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"139 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"110 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"92 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"78 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"75 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"74 reports"},{"date":"","signal":"DRY SKIN","source":"FDA FAERS","actionTaken":"71 reports"},{"date":"","signal":"ALOPECIA","source":"FDA FAERS","actionTaken":"69 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"69 reports"}],"commonSideEffects":[{"effect":"Burning and stinging","drugRate":"10%","severity":"mild","organSystem":""},{"effect":"Pruritus","drugRate":"7%","severity":"mild","organSystem":""},{"effect":"Erythema","drugRate":"1.5%","severity":"mild","organSystem":""},{"effect":"Numbness","drugRate":"1.5%","severity":"mild","organSystem":""},{"effect":"Tingling","drugRate":"1.5%","severity":"mild","organSystem":""},{"effect":"Rash","drugRate":"1.5%","severity":"mild","organSystem":""},{"effect":"Headache","drugRate":"","severity":"mild","organSystem":""},{"effect":"Fever","drugRate":"","severity":"mild","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"mild","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"mild","organSystem":""},{"effect":"Diarrhea","drugRate":"","severity":"mild","organSystem":""},{"effect":"Nausea and/or vomiting","drugRate":"","severity":"mild","organSystem":""}],"contraindications":["Bronchospasm"],"specialPopulations":{"Pregnancy":"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.","Geriatric use":"Clinical studies of permethrin cream, 5% did not identify sufficient numbers of subjects aged 65 and over to allow 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","Paediatric use":"Permethrin cream, 5% 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."},"seriousAdverseEvents":[{"effect":"Seizure","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.2721/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$99","description":"PERMETHRIN 5% CREAM","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PERMETHRIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:03:37.818789+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada 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(no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:03:34.827035+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:03:46.877953+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Voltage-sensitive sodium channel blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:03:45.957310+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1525/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:03:45.850820+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA076090","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:03:34.827043+00:00"}},"allNames":"elimite","offLabel":[],"synonyms":["permethrin"],"timeline":[{"date":"1986-03-31","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1990-05-02","type":"positive","source":"FDA Orange Book","milestone":"Nix approved — 1%"},{"date":"2003-04-21","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 4 manufacturers approved"}],"approvals":[{"date":"1986-03-31","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Elimite","ecosystem":[{"indication":"Infestation by Phthirus pubis","otherDrugs":[{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"},{"name":"lindane","slug":"lindane","company":"Reed And Carnrick"},{"name":"piperonyl butoxide","slug":"piperonyl-butoxide","company":"Bayer Healthcare Llc"},{"name":"pyrethrins","slug":"pyrethrins","company":"Bayer Healthcare Llc"}],"globalPrevalence":null},{"indication":"Infestation by Sarcoptes scabiei var hominis","otherDrugs":[{"name":"crotamiton","slug":"crotamiton","company":"Ranbaxy"},{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"},{"name":"lindane","slug":"lindane","company":"Reed And Carnrick"}],"globalPrevalence":null},{"indication":"Pediculosis Prevention","otherDrugs":[],"globalPrevalence":null},{"indication":"Pediculosis capitis","otherDrugs":[{"name":"abametapir","slug":"abametapir","company":"Dr Reddys Labs Sa"},{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"},{"name":"lindane","slug":"lindane","company":"Reed And Carnrick"},{"name":"malathion","slug":"malathion","company":"Taro Pharms North"}],"globalPrevalence":null},{"indication":"Pediculosis corporis","otherDrugs":[{"name":"piperonyl butoxide","slug":"piperonyl-butoxide","company":"Bayer Healthcare Llc"},{"name":"pyrethrins","slug":"pyrethrins","company":"Bayer Healthcare Llc"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"Pyrethroid [EPC]","explanation":"","oneSentence":"","technicalDetail":"Permethrin is a type II pyrethroid that acts as a sodium channel modulator, inhibiting the voltage-gated sodium channels in the nervous system of lice and scabies mites, leading to hyperexcitation and eventual death."},"commercial":{"launchDate":"1986","_launchSource":"DrugCentral (FDA 1986-03-31, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4152","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PERMETHRIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PERMETHRIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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