{"active_ingredient":["Carbamide Peroxide 6.5%"],"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 of age: consult a doctor."],"effective_time":"20240108","id":"bac0c4d3-f01c-4ade-a739-51480e272328","inactive_ingredient":["Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water"],"indications_and_usage":["For occasional use as an aid to soften. loosen and remove excessive earwax."],"keep_out_of_reach_of_children":["If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M014"],"brand_name":["Ear Drops Major"],"generic_name":["CARBAMIDE PEROXIDE 6.5%"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["0904-6627"],"package_ndc":["50090-5273-0"],"product_ndc":["50090-5273"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["bac0c4d3-f01c-4ade-a739-51480e272328"],"spl_set_id":["eb7df1cc-50db-479a-bc1c-dfd7004dd35b"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"]},"package_label_principal_display_panel":["Carbamide Peroxide 6.5% Label Image"],"purpose":["Earwax Removal Aid"],"set_id":"eb7df1cc-50db-479a-bc1c-dfd7004dd35b","spl_product_data_elements":["Ear Drops Major Carbamide Peroxide 6.5% SODIUM STANNATE GLYCERIN ANHYDROUS CITRIC ACID PROPYLENE GLYCOL SODIUM LAUROYL SARCOSINATE WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"version":"6","warnings":["Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with eyes Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away"]}