{"id":"carbamide-peroxide","rwe":[],"_fda":{"id":"205c56d8-c376-6d56-e063-6294a90a3535","set_id":"0022a174-8377-44af-84a9-31adb27de131","openfda":{"upc":["0096295143782"],"unii":["31PZ2VAU81"],"route":["TOPICAL"],"rxcui":["702050"],"spl_id":["205c56d8-c376-6d56-e063-6294a90a3535"],"brand_name":["Leader Earwax Removal Drops Earwax Removal Aid"],"spl_set_id":["0022a174-8377-44af-84a9-31adb27de131"],"package_ndc":["70000-0688-1"],"product_ndc":["70000-0688"],"generic_name":["CARBAMIDE PEROXIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CARBAMIDE PEROXIDE"],"manufacturer_name":["Cardinal Health, Inc."],"application_number":["M014"],"is_original_packager":[true]},"purpose":["Purpose Earwax removal aid"],"version":"3","stop_use":["Stop use and ask a doctor if you need to use for more than 4 days excessive earwax remains after use of this product"],"warnings":["Warnings For use in the ear only Ask a doctor before use if you have ear drainage or discharge ear pain irritation, or rash in the ear dizziness an injury or perforation (hole) of the ear drum recently had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than 4 days excessive earwax remains after use of this product Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"questions":["Questions? 1-800-328-5890 Weekdays 8:30-5:00 CST"],"ask_doctor":["Ask a doctor before use if you have ear drainage or discharge ear pain irritation, or rash in the ear dizziness an injury or perforation (hole) of the ear drum recently had ear surgery"],"when_using":["When using this product avoid contact with the eyes"],"effective_time":"20240823","active_ingredient":["Active ingredient Carbamide peroxide 6.5% Purpose Earwax removal aid"],"inactive_ingredient":["Inactive ingredients anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water"],"indications_and_usage":["Uses for occasional use as an aid to soften, loosen, and remove excessive earwax"],"spl_unclassified_section":["Drug Facts","Other information Avoid exposing bottle to excessive heat and direct sunlight Store bottle in the outer carton Store at 15-30ºC (59-86ºF) Keep cap on bottle when not in use Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound. Do not use if tamper-evident safety seal is broken or missing"],"dosage_and_administration":["Directions FOR USE IN THE EAR ONLY Adults and children over 12 years of age: Tilt head sideways and place 5 to 10 drops into ear Tip of applicator should not enter ear canal Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear Use twice daily for up to 4 days if needed, or as directed by a doctor Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe Children under 12 years: consult a doctor"],"spl_product_data_elements":["Leader Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL SODIUM CITRATE SODIUM LAURYL SULFATE WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"package_label_principal_display_panel":["Package Labeling: Label Inner label"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Dental","category":"route"},{"label":"Auricular (Otic)","category":"route"},{"label":"Gel","category":"form"},{"label":"Liquid","category":"form"},{"label":"Active","category":"status"},{"label":"Impacted cerumen","category":"indication"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Local","category":"pharmacology"},{"label":"Bleaching Agents","category":"pharmacology"},{"label":"Oxidants","category":"pharmacology"},{"label":"Tooth Bleaching Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"33 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"19 reports"},{"date":"","signal":"CHRONIC KIDNEY DISEASE","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"17 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"17 reports"}],"contraindications":["Chronic purulent otitis media","Ear Redness","Infection of ear","Injury of ear","Irritation of ear","Itching of ear","Otalgia","Perforation of tympanic membrane","Procedure on ear"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=carbamide peroxide","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:04:50.797632+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:05:09.339045+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:04:56.188334+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=carbamide peroxide","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:04:56.481182+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:04:49.376124+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:05:04.268540+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:04:49.376154+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":"2026-04-20T01:04:57.937073+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL71595/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:04:57.176754+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M014","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:04:49.376158+00:00"}},"allNames":["carbamide peroxide"],"offLabel":[],"synonyms":["carbamide peroxide"],"timeline":[],"aiSummary":"Carbamide peroxide is a marketed drug primarily indicated for earwax removal, with a key composition patent expiring in 2028. 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