{"active_ingredient":["Active ingredient Carbamide peroxide 6.5%"],"ask_doctor":["Ask a doctor before use if you have • ear drainage or discharge • ear pain, irritation, rash or are dizzy • an injury or perforation (hole) of the eardrum or if you had ear surgery"],"do_not_use":["Do not use for more than 4 days"],"dosage_and_administration":["Directions FOR USE IN THE EAR ONLY adults and children over 12 years: • 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 tilting head or placing cotton in ear • use twice daily for up to 4 days • remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe children under 12 years: ask a doctor"],"effective_time":"20190906","id":"5dc265ba-1712-442a-a9be-95fb71557359","inactive_ingredient":["Inactive ingredients citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine"],"indications_and_usage":["Use softens, loosens and removes excessive earwax"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 mL Carton COMPARE TO ACTIVE INGREDIENT IN DEBROX ® * Rugby ® NDC 0536-3000-94 Earwax Treatment Drops Carbamide Peroxide 6.5 % Helps Remove Excessive Earwax 1/2 fl oz (15 mL) SATISFACTION GUARANTEED Rugby OR YOUR MONEY BACK Principal Display Panel - 15 mL Carton"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions or comments? Call 1-800-645-2158 9am - 5pm ET Monday - Friday"],"set_id":"b31d2529-c7a3-46fc-8e93-f69515a8934b","spl_product_data_elements":["Ear Wax Treatment Carbamide Peroxide CARBAMIDE PEROXIDE HYDROGEN PEROXIDE Water Citric Acid Monohydrate Glycerin Sodium Acid Pyrophosphate SODIUM CITRATE, UNSPECIFIED FORM Propylene Glycol Trolamine Colorless to pale yellow"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if earwax remains longer than 4 days"],"storage_and_handling":["Other information • store at room temperature 15° - 30°C (59° - 89°F) • keep in a dry place"],"version":"2","warnings":["Warnings Do not use for more than 4 days Ask a doctor before use if you have • ear drainage or discharge • ear pain, irritation, rash or are dizzy • an injury or perforation (hole) of the eardrum or if you had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if earwax remains longer than 4 days Keep out of 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"]}