{"active_ingredient":["Active ingredient Carbamide peroxide 6.5% non USP* *pH differs from USP specifications"],"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 eardrum • recently had ear surgery"],"dosage_and_administration":["Directions FOR USE IN THE EAR ONLY adults and children over 12 years of age: • tilt head sideways • 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 four 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"],"effective_time":"20250501","id":"763250f2-0ac4-4518-a6b7-2d5aa90da288","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water"],"indications_and_usage":["Uses for occasional use as an aid to soften, loosen, and remove excessive earwax"],"keep_out_of_reach_of_children":["Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Debrox® DROPS Carbamide Peroxide 6.5% Non USP* Earwax Removal Aid Kit includes soft rubber bulb ear syringe and drops ½ FL OZ (15mL) 71205-136-15"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions or comments? call toll-free 1-866-255-5202 Debrox.com"],"set_id":"e1dacadf-cfb4-4a06-9858-dd6fba2975f8","spl_product_data_elements":["DEBROX Carbamide Peroxide CARBAMIDE PEROXIDE HYDROGEN PEROXIDE CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL SODIUM LAUROYL SARCOSINATE WATER"],"spl_unclassified_section":["Drug Facts","Other information • do not store above 25C (77F) • store bottle in the outer carton • product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound. • keep tip on bottle when not in use"],"stop_use":["Stop use and ask a doctor if • you need to use for more than four days • excessive earwax remains after use of this product"],"version":"5","warnings":["Warnings 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 eardrum • 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 four days • excessive earwax remains after use of this product Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product avoid contact with the eyes"]}