{"id":"talc","rwe":[],"_fda":{"id":"2474d4ae-87b7-2b9e-e063-6394a90a67bf","set_id":"0201dfee-75a3-4aad-9dee-eedc38db1758","openfda":{"unii":["VW4H1CYW1K"],"route":["TOPICAL"],"rxcui":["998428"],"spl_id":["2474d4ae-87b7-2b9e-e063-6394a90a67bf"],"brand_name":["Miconazole Nitrate"],"spl_set_id":["0201dfee-75a3-4aad-9dee-eedc38db1758"],"package_ndc":["41250-196-46"],"product_ndc":["41250-196"],"generic_name":["ATHLETES FOOT POWDER SPRAY TALC FREE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["MICONAZOLE NITRATE"],"manufacturer_name":["Meijer Distribution Inc"],"application_number":["M005"],"is_original_packager":[true]},"purpose":["Purpose Antifungal"],"version":"6","stop_use":["Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch"],"warnings":["For external use only. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor. Do not use on children under 2 years of age unless directed by a doctor."],"questions":["Questions? Call 1-866-964-0939"],"do_not_use":["Do not use on children under 2 years of age unless directed by a doctor."],"when_using":["When using this product avoid contact with the eyes or mouth use only as directed"],"effective_time":"20241014","active_ingredient":["Active ingredient Miconazole nitrate 2%"],"inactive_ingredient":["Inactive ingredients disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch"],"indications_and_usage":["Uses cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris) relieves symptoms of athlete's foot, including itching, burning and cracking"],"safe_handling_warning":["Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal."],"other_safety_information":["Other information store between 20º and 30ºC (68ºF and 86º)"],"dosage_and_administration":["Directions wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch; if conditions persists, consult a doctor this product is not effective on the scalp or nails if nozzle clogs, clean with a pin"],"spl_product_data_elements":["Miconazole Nitrate Athletes Foot Powder Spray Talc Free DISTEARDIMONIUM HECTORITE ISOBUTANE KAOLIN ALCOHOL ZEA MAYS SUBSP. MAYS WHOLE MICONAZOLE NITRATE MICONAZOLE"],"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. Do not use on children under 2 years of age unless directed by a doctor."],"package_label_principal_display_panel":["Principal Display Panel meijer MEDICATED athlete's foot Miconazole Nitrate | Antifungal Powder Spray TALC-FREE Cures most athlete's foot Relieves itching, cracking & burning NET WT 4.6 OZ (130g) AF Miconazole Powder Spray"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Intrapleural","category":"route"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cream","category":"form"},{"label":"Powder","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Inoperable secondary intractable pneumothorax","category":"indication"},{"label":"Suppression of recurrence of malignant pleural effusions","category":"indication"},{"label":"Nobelpharma Co., Ltd.","category":"company"},{"label":"Antiperspirants","category":"pharmacology"},{"label":"Cosmetics","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"386 reports"},{"date":"","signal":"EXPOSURE TO CHEMICAL POLLUTION","source":"FDA FAERS","actionTaken":"327 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"280 reports"},{"date":"","signal":"INJURY","source":"FDA FAERS","actionTaken":"224 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"219 reports"},{"date":"","signal":"MESOTHELIOMA","source":"FDA FAERS","actionTaken":"189 reports"},{"date":"","signal":"VULVOVAGINAL BURNING SENSATION","source":"FDA FAERS","actionTaken":"174 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"160 reports"},{"date":"","signal":"DISABILITY","source":"FDA FAERS","actionTaken":"143 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"142 reports"}],"commonSideEffects":[{"effect":"Fever","drugRate":"","severity":"common","organSystem":""},{"effect":"Pain","drugRate":"","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"STERITALC(R) is contraindicated for use in pregnant women because it contains lead, which can cause fetal harm and potential loss of pregnancy. There are no human data on the use of STERITALC(R) in pregnant women. In an animal reproduction study, oral administration of talc in pregnant rabbits during organogenesis revealed no evidence of teratogenicity at dose up to approximately 5-fold the human dose.","Geriatric use":"The mean and median ages of patients treated with talc in the clinical studies table were 50-62 years. No analyses to specifically evaluate the safety and efficacy in the geriatric population have been reported.","Paediatric use":"The safety and efficacy of Sclerosol Intrapleural Aerosol(R) (sterile talc powder) in pediatric patients have not been established."},"seriousAdverseEvents":[{"effect":"Empyema","drugRate":"","severity":"serious"},{"effect":"Pneumonia","drugRate":"","severity":"serious"},{"effect":"ARDS","drugRate":"","severity":"serious"},{"effect":"Bronchopleural fistula","drugRate":"","severity":"serious"},{"effect":"Hemoptysis","drugRate":"","severity":"serious"},{"effect":"Pulmonary emboli","drugRate":"","severity":"serious"},{"effect":"Myocardial infarction","drugRate":"","severity":"serious"},{"effect":"Asystolic arrest","drugRate":"","severity":"serious"},{"effect":"Subcutaneous empyema","drugRate":"","severity":"serious"},{"effect":"Adenocarcinoma of the chest wall","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Nobelpharma Co., Ltd.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TALC","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:12:27.068911+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:12:33.770508+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:12:26.044361+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TALC","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:12:34.219316+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:12:25.536533+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:12:25.536567+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":"2026-04-20T01:12:35.774754+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989756/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:12:34.978755+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M005","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:12:25.536572+00:00"}},"allNames":"sclerosol","offLabel":[],"synonyms":["talc","sterile talc","unitalc"],"timeline":[{"date":"1997-12-24","type":"positive","source":"FDA Orange Book","milestone":"Sclerosol approved — 4GM/SPRAY"},{"date":"2013-09-23","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Nobelpharma Co., Ltd.)"},{"date":"2017-05-01","type":"positive","source":"FDA Orange Book","milestone":"Steritalc approved — 2GM/VIAL"}],"aiSummary":"Sclerosol (TALC) is a small molecule modality developed by Nobelpharma Co., Ltd. and currently owned by Sciarra Labs. It is approved for the treatment of inoperable secondary intractable pneumothorax and suppression of recurrence of malignant pleural effusions. Despite being off-patent, there are no generic manufacturers available. Key safety considerations include its use as a sclerosing agent, which can cause inflammation and fibrosis. Sclerosol (TALC) is used to induce scarring in the pleural space to prevent further fluid accumulation.","approvals":[{"date":"2013-09-23","orphan":true,"company":"Nobelpharma Co., Ltd.","regulator":"PMDA"},{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Sclerosol","ecosystem":[{"indication":"Inoperable secondary intractable pneumothorax","otherDrugs":[],"globalPrevalence":null},{"indication":"Suppression of recurrence of malignant pleural effusions","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Sclerosol (TALC) is a talc-based sclerosing agent that works by inducing a localized inflammatory response in the pleural space, leading to the formation of fibrotic tissue and subsequent obliteration of the pleural space."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5190","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TALC","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TALC","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 Book"}],"_enrichedAt":"2026-03-30T15:47:54.041630","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:12:37.065180+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"talc","indications":{"approved":[{"name":"Inoperable secondary intractable pneumothorax","source":"DrugCentral","snomedId":328571000119101,"regulator":"FDA","eligibility":"no eligibility criteria provided"},{"name":"Suppression of recurrence of malignant pleural effusions","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"no eligibility criteria provided"}],"offLabel":[],"pipeline":[]},"currentOwner":"Sciarra Labs","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[],"trialDetails":[{"nctId":"NCT06898606","phase":"PHASE1,PHASE2","title":"Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression","status":"RECRUITING","sponsor":"Federal University of Latin American Integration","startDate":"2024-09-05","conditions":["Depressive Disorder"],"enrollment":24,"completionDate":"2026-11-20"},{"nctId":"NCT07440394","phase":"NA","title":"Evaluation of Pine Bark Extract for Anti-fatigue Ergogenic Properties","status":"COMPLETED","sponsor":"China Medical 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