{"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":"20250130","id":"51f0bf52-f4e9-4ffc-8483-4a6632c42c58","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, sodium stannate, 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 right away."],"openfda":{},"other_safety_information":["Other information do not store above 77F (25C) 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"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Debrox ® DROPS Carbamide Peroxide 6.5% Non USP* Earwax Removal Aid Kit includes soft rubber bulb ear syringe and drops ½ FL OZ (15mL) PRINCIPAL DISPLAY PANEL Debrox DROPS Carbamide Peroxide 6.5% Non USP* Earwax Removal Aid Kit includes soft rubber bulb ear syringe and drops ½ FL OZ (15mL)"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions or comments? call toll-free 1-866-255-5202 (English/Spanish) weekdays"],"set_id":"755d3234-2df4-4464-a2c5-b04276065fc5","spl_product_data_elements":["DEBROX Carbamide Peroxide CARBAMIDE PEROXIDE HYDROGEN PEROXIDE CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL SODIUM LAUROYL SARCOSINATE SODIUM STANNATE WATER"],"spl_unclassified_section":["Drug Facts"],"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":"9","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 right away."],"when_using":["When using this product avoid contact with the eyes"]}