{"id":"alcohol-50","_fda":{"id":"36ed1f59-5893-70ef-e063-6294a90aeaa6","set_id":"36ed1f27-d266-7316-e063-6394a90aa9d4","openfda":{"upc":["0850025020381"],"unii":["ND2M416302"],"route":["TOPICAL"],"rxcui":["616456"],"spl_id":["36ed1f59-5893-70ef-e063-6294a90aeaa6"],"brand_name":["Isopropyl Rubbing Alcohol Orazen Inc"],"spl_set_id":["36ed1f27-d266-7316-e063-6394a90aa9d4"],"package_ndc":["71927-025-01"],"product_ndc":["71927-025"],"generic_name":["ISOPROPYL ALCOHOL 50 %"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ISOPROPYL ALCOHOL"],"manufacturer_name":["Orazen Inc"],"application_number":["505G(a)(3)"],"is_original_packager":[true]},"purpose":["Purpose First aid antiseptic"],"version":"8","stop_use":["Stop use and ask a doctor if condition persists or gets worse"],"warnings":["Warnings For external use only Flammable, keep away from fire or flame. use only in a well-ventilated area; fumes may be toxic if taken internally serious gastric disturbances will result Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns When using this product do not get into eyes do not apply over large areas of the body do not use longer than one week unless directed by a doctor Stop use and ask a doctor if condition persists or gets worse Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away."],"questions":["Questions or comments? Call toll-free 1-888-672-9360 (M-F 9AM-5:30PM EST)"],"ask_doctor":["Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns"],"when_using":["When using this product do not get into eyes do not apply over large areas of the body do not use longer than one week unless directed by a doctor"],"effective_time":"20250605","active_ingredient":["Active ingredient (by volume) Isopropyl alcohol (50% conc.)"],"inactive_ingredient":["Inactive ingredient purified water"],"storage_and_handling":["Other information store at room temperature does not contain, nor is intended as a substitute for grain or ethyl alcohol"],"indications_and_usage":["Uses first aid to help prevent the risk of infection in minor cuts, scrapes and burns"],"spl_unclassified_section":["Drug Facts"],"dosage_and_administration":["Directions clean affected area apply small amount of this product on the area 1-3 times daily if bandaged, let dry first may be covered with a sterile bandage"],"spl_product_data_elements":["Isopropyl Rubbing Alcohol Orazen Inc Isopropyl alcohol 50 % WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label QUALITY GUARANTEED Isopropyl Rubbing Alcohol, 50% First Aid Antiseptic For treatment of Minor Cuts Scrapes Burns 12 FL OZ 354 mL Orazen Inc Item # 02038 Our Brand Rubbing Alcohol 50 %"]},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"APPLICATION SITE PERSPIRATION","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"DRUG ADMINISTRATION ERROR","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"NONSPECIFIC REACTION","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ORAL HERPES","source":"FDA FAERS","actionTaken":"1 reports"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Alcohol 50%","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:51:15.637154+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T04:51:35.313230+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:51:22.209392+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Alcohol 50%","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:51:23.009758+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:51:13.181858+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:51:30.301375+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:51:13.181885+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":"2026-04-20T04:51:24.863756+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL720/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:51:23.867076+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"505G(a)(3)","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:51:13.181888+00:00"}},"_dailymed":{"setId":"3ad79e91-377d-6587-e054-00144ff8d46c","title":"NOVITA ISOPROPYL ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [SHIELD LINE LLC]"},"aiSummary":"Alcohol 50% is a marketed product by Tanta University, primarily indicated for the prevention of infection in minor injuries. The key composition patent is set to expire in 2028, providing a clear timeline for potential generic competition. The primary risk lies in the lack of revenue data and key trial results, which may limit the drug's market visibility and investor confidence.","_scrapedAt":"2026-03-28T05:52:11.858Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T04:51:35.313589+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"alcohol-50-prevention-of-infection-in-min","name":"Prevention of infection in minor injuries","dosing":null,"approvals":[],"diseaseId":"","eligibility":"General population","pivotalTrial":null,"restrictions":[],"patientPopulation":"General population","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT06065657","phase":"PHASE2, PHASE3","title":"Effect of Nutritional Ketosis on Alcohol Metabolism","status":"RECRUITING","sponsor":"University of Pennsylvania","startDate":"2024-02-29","conditions":"Ketoses, Metabolic, Ketogenic Dieting, Alcohol 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