{"id":"crotamiton","rwe":[{"pmid":"41502969","year":"2025","title":"Efficacy and Safety of Gliricidia sepium, Senna alata, and Tinospora rumphii in the Treatment of Filipino Patients with Scabies: A Systematic Review and Meta-analysis.","finding":"","journal":"Acta medica Philippina","studyType":"Clinical Study"},{"pmid":"41124606","year":"2026","title":"Occurrence and fate of pharmaceuticals and personal care products in river water, lake water, sewage effluent, tap water, and groundwater in Japan.","finding":"","journal":"Environmental toxicology and chemistry","studyType":"Clinical Study"},{"pmid":"40703982","year":"2024","title":"Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 2. Treatment and prevention - a secondary publication.","finding":"","journal":"Ewha medical journal","studyType":"Clinical Study"},{"pmid":"37655266","year":"2023","title":"Recalcitrant nodular scabies showing excellent response to tofacitinib: five case reports.","finding":"","journal":"Therapeutic advances in chronic disease","studyType":"Clinical Study"},{"pmid":"37625798","year":"2024","title":"Failure of scabies treatment: a systematic review and meta-analysis.","finding":"","journal":"The British journal of dermatology","studyType":"Clinical Study"}],"_fda":{"id":"36991086-14b5-9e66-e063-6394a90ad654","set_id":"3699175f-bfc8-a047-e063-6394a90a80d1","openfda":{"upc":["0373352051106"],"unii":["D6S4O4XD0H"],"route":["TOPICAL"],"rxcui":["106219"],"spl_id":["36991086-14b5-9e66-e063-6394a90ad654"],"brand_name":["Pruradik"],"spl_set_id":["3699175f-bfc8-a047-e063-6394a90a80d1"],"package_ndc":["73352-051-10"],"product_ndc":["73352-051"],"generic_name":["CROTAMITON"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CROTAMITON"],"manufacturer_name":["Trifluent Pharma, LLC"],"application_number":["ANDA087204"],"is_original_packager":[true]},"version":"1","warnings":["WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted."],"pregnancy":["Pregnancy (Category C): Animal reproduction studies have not been conducted with Pruradik (crotamiton USP) lotion. It is also not known whether Pruradik can cause fetal harm when applied to a pregnant woman or can affect reproduction capacity. Pruradik should be given to a pregnant woman only if clearly needed."],"overdosage":["OVERDOSAGE: There is no specific informaton on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed. Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain. If accidental ingestion occurs, call your Poison Control Center."],"precautions":["PRECAUTIONS: General: Pruradik lotion should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until acute inflammation has subsided."],"how_supplied":["HOW SUPPLIED: Pruradik (crotamitan USP) lotion, 10% is available in: 237 gm ( NDC : 73352-051-10) Rx ONLY Mfd For: Trifluent Pharma, LLC San Antonio TX 78213 Rev 01 May 2025"],"geriatric_use":["Geriatric Use: Clinical studies with Pruradik (crotamiton USP) lotion did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out."],"pediatric_use":["Pediatric Use: Safety and effectiveness in children have not been established."],"effective_time":"20250602","adverse_reactions":["ADVERSE REACTIONS: Primary irritation reactions such as dermatitis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients. To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS: Pruradik lotion should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications."],"drug_interactions":["Drug Interactions: None known."],"storage_and_handling":["STORAGE: Store 20 ° to 25 º C (68 ° - 77 ° F). Excursions allowed between 15 ° and 30 ° C (59 ° and 86 ° F) [See USP Controlled Room Temperature]."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Pruradik ™ lotion has scabicial and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined."],"indications_and_usage":["Pruradik ™ (crotamiton USP 10%) is a scabicidal and antipruritic agent as a lotion for topical use only. Crotamiton is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203. 28. Crotamiton is N-ethyl-N(o-methyl-phenyl) 2-butenamide and its structural formula is: Pruradik lotion contains crotamiton USP 10% (100mg/ml) in a creamy lotion base containing purified water, light mineral oil, propylene glycol, cetearyl alcohol (and) cetearth-20, cetyl alcohol, lanolin, benzyl alcohol, carbomer 971P, sodium hydroxide with citric acid (for pH adjustment). image description","INDICATIONS AND USAGE: For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin."],"warnings_and_cautions":["FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx ONLY"],"information_for_patients":["Information for Patients: See \"DIRECTIONS FOR PATIENTS WITH SCABIES.\""],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USE. In Scabies: Thoroughly massage into the skin of the whole body, from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application. In Pruritis: Massage gently into affected areas until medication is completely absorbed. Repeat as needed. DIRECTIONS FOR PATIENTS WITH SCABIES: 1. Take a routine bath or shower. Thoroughly massage Pruradik ™ lotion into the skin from the chin to the toes including folds and creases. 2. Put Pruradik lotion under fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply the Pruradik lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the brush in the mouth could lead to poisoning. 3. A second application is advisable 24 hours leater. 4. Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned or washed in the hot cycle of the washing machine. 5. A cleansing bath should be taken 48 hours after the last application."],"spl_product_data_elements":["Pruradik Crotamiton WATER MINERAL OIL PROPYLENE GLYCOL CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER CETYL ALCOHOL LANOLIN BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE A SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE CROTAMITON CROTAMITON"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN."],"package_label_principal_display_panel":["Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutangenesis, Impairment of Fertility: Long-term carcinogenicity studies in animals have not been conducted."]},"tags":[{"label":"crotamiton","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Topical","category":"route"},{"label":"Lotion","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Infestation by Sarcoptes scabiei var hominis","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Journey","category":"company"},{"label":"Approved 1940s","category":"decade"},{"label":"Pesticides","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":38.924,"date":"","count":17,"signal":"Hepatic function abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=39)"},{"llr":38.543,"date":"","count":12,"signal":"Hepatomegaly","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=39)"},{"llr":38.047,"date":"","count":17,"signal":"Rash pruritic","source":"DrugCentral FAERS","actionTaken":"Reported 17 times (LLR=38)"}],"commonSideEffects":[{"effect":"dermititis","drugRate":"reported","severity":"unknown"},{"effect":"pruritus","drugRate":"reported","severity":"unknown"},{"effect":"rash","drugRate":"reported","severity":"unknown"},{"effect":"allergic sensitivity reactions","drugRate":"reported","severity":"unknown"}],"contraindications":["Denuded skin","Inflammatory dermatosis"],"specialPopulations":{"Pregnancy":"Animal reproduction studies have not been conducted with CROTAN (crotamiton USP) lotion. It is also not known whether CROTAN can cause fetal harm when applied to pregnant woman or can affect reproduction capacity. CROTAN should be given to pregnant woman only if clearly needed.","Geriatric use":"Clinical studies with CROTAN (crotamiton USP) lotion did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but great sensitivity of some older individuals cannot be ruled out.","Paediatric use":"Safety and effectiveness in children have not been established."}},"trials":[],"aliases":[],"company":"Journey","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CROTAMITON","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:29:50.010950+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:29:55.722031+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CROTAMITON","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:29:56.232578+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:29:48.896522+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:29:48.896550+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6067975/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:29:57.024999+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS: Primary irritation reactions such as dermatitis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients. To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:30:01.070688+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA087204","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:29:48.896554+00:00"}},"allNames":"eurax","offLabel":[],"synonyms":["crotamiton","crotalgin","crotamitex","crotamitone","veteusan","N-Crotonyl-N-ethyl-o-toluidine"],"timeline":[{"date":"1949-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from RANBAXY to Journey"},{"date":"1949-07-06","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ranbaxy)"}],"aiSummary":"Eurax (Crotamiton) is a small molecule drug originally developed by Ranbaxy and currently owned by Journey. It is used to treat infestation by Sarcoptes scabiei var hominis and itching of the skin. Eurax is an off-patent medication with no active Orange Book patents, making it available as a generic. It has been FDA-approved since 1949. As a crotamiton, Eurax works by reducing itching and killing scabies mites.","approvals":[{"date":"1949-07-06","orphan":false,"company":"RANBAXY","regulator":"FDA"}],"brandName":"Eurax","ecosystem":[{"indication":"Infestation by Sarcoptes scabiei var hominis","otherDrugs":[{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"},{"name":"lindane","slug":"lindane","company":"Reed And Carnrick"},{"name":"permethrin","slug":"permethrin","company":""}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"crotamiton","explanation":"","oneSentence":"","technicalDetail":"Crotamiton, the active ingredient in Eurax, is thought to work by disrupting the cell membrane of scabies mites, ultimately leading to their death. It also has antipruritic properties, which help to reduce itching by blocking the transmission of itch signals to the brain."},"commercial":{"launchDate":"1949","_launchSource":"DrugCentral (FDA 1949-07-06, RANBAXY)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/744","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CROTAMITON","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:23:33.921108","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:30:02.825697+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"crotamiton","indications":{"approved":[{"name":"Infestation by Sarcoptes scabiei var hominis","source":"DrugCentral","snomedId":128869009,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Itching of skin","source":"DrugCentral","snomedId":418363000,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"}],"offLabel":[],"pipeline":[]},"currentOwner":"Journey","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Lotion","formulations":[{"form":"LOTION","route":"TOPICAL","productName":"Crotan"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146972","MMSL":"4511","NDDF":"002993","UNII":"D6S4O4XD0H","VUID":"4018661","CHEBI":"CHEBI:31439","VANDF":"4018661","INN_ID":"673","RXNORM":"21766","UMLSCUI":"C0056519","chemblId":"CHEMBL6067975","ChEMBL_ID":"CHEMBL1200709","KEGG_DRUG":"D01381","DRUGBANK_ID":"DB00265","PUBCHEM_CID":"688020","SNOMEDCT_US":"387515007","IUPHAR_LIGAND_ID":"11165","MESH_SUPPLEMENTAL_RECORD_UI":"C005553"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1949-","companyName":"Ranbaxy","relationship":"Original Developer"},{"period":"present","companyName":"Journey","relationship":"Current Owner"}],"publicationCount":146,"therapeuticAreas":["Dermatology"],"biosimilarFilings":[],"originalDeveloper":"Ranbaxy","recentPublications":[{"date":"2025","pmid":"41502969","title":"Efficacy and Safety of Gliricidia sepium, Senna alata, and Tinospora rumphii in the Treatment of Filipino Patients with Scabies: A Systematic Review and Meta-analysis.","journal":"Acta medica Philippina"},{"date":"2026 Jan 1","pmid":"41124606","title":"Occurrence and fate of pharmaceuticals and personal care products in river water, lake water, sewage effluent, tap water, and groundwater in Japan.","journal":"Environmental toxicology and chemistry"},{"date":"2024 Oct","pmid":"40703982","title":"Clinical practice guidelines for the diagnosis and treatment of scabies in Korea: Part 2. Treatment and prevention - a secondary publication.","journal":"Ewha medical journal"},{"date":"2023","pmid":"37655266","title":"Recalcitrant nodular scabies showing excellent response to tofacitinib: five case reports.","journal":"Therapeutic advances in chronic disease"},{"date":"2024 Jan 23","pmid":"37625798","title":"Failure of scabies treatment: a systematic review and meta-analysis.","journal":"The British journal of dermatology"}],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Legacy Pharma"],"status":"approved","companyName":"Journey","companyId":"journey","modality":"Small Molecule","firstApprovalDate":"1949","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1949-07-06T00:00:00.000Z","mah":"RANBAXY","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:30:02.825697+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":false,"score":2}}