{"active_ingredient":["Carbamide Peroxide 6.5%"],"dosage_and_administration":["Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal."],"effective_time":"20231215","id":"0c93a2f8-8199-15fb-e063-6394a90a5521","inactive_ingredient":["Citric Acid Flavor Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Purified Water"],"indications_and_usage":["For occasional use as an aid to soften, loosen and remove excessive earwax."],"keep_out_of_reach_of_children":["Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M014"],"brand_name":["Earwax Removal Drops"],"generic_name":["CARBAMIDE PEROXIDE 6.5%"],"is_original_packager":[true],"manufacturer_name":["Humco Holding Group, Inc"],"package_ndc":["0395-9133-90","0395-9133-45"],"product_ndc":["0395-9133"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"spl_id":["0c93a2f8-8199-15fb-e063-6394a90a5521"],"spl_set_id":["a8c052d8-fb9c-09f2-e053-2a95a90a37af"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"],"upc":["0096295137040"]},"package_label_principal_display_panel":["CVS Label CVSWax.jpg carton","Leader Label Leader2022 LDREarwax45.jpg LDREwawax90.jpg","Rite Aid Label Rite Aid Earwax Kit 2022 RAEarwax45.jpg RAEarwax90.jpg","Major Label MajorEarwax90.jpg"],"purpose":["Earwax removal aid."],"set_id":"a8c052d8-fb9c-09f2-e053-2a95a90a37af","spl_product_data_elements":["Earwax Removal Drops Carbamide Peroxide 6.5% WATER SODIUM STANNATE SODIUM LAUROYL SARCOSINATE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"version":"5","warnings":["For External Use Only. Ask a doctor before use if you have: Ear drainage or discharge Ear pain, irritation, or rash in the ear Recently had ear surgery Dizziness An injury or perforation (hole) of the eadrum"]}