{"active_ingredient":["OTC - ACTIVE INGREDIENT Carbamide peroxide 6.5% non USP* *pH differs from USP specifications"],"dosage_and_administration":["DOSAGE & ADMINISTRATION 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":"20170313","id":"4aa39545-569b-658d-e054-00144ff88e88","inactive_ingredient":["INACTIVE INGREDIENT citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, sodium stannate, water"],"indications_and_usage":["INDICATIONS & USAGE for occasional use as an aid to soften, loosen, and remove excessive earwax"],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION DRUG: DEBROX GENERIC: Carbamide Peroxide DOSAGE: LIQUID ADMINSTRATION: AURICULAR (OTIC) NDC: 61786-185-15 ACTIVE INGREDIENT(S): CARBAMIDE PEROXIDE 0.065mg in 1mL INACTIVE INGREDIENT(S): CITRIC ACID MONOHYDRATE SODIUM LAUROYL SARCOSINATE SODIUM STANNATE GLYCERIN PROPYLENE GLYCOL WATER PACKAGING: 15 mL in 1 BOTTLE, DROPPER OUTER PACKAGING: 1 BOTTLE in 1 CARTON MM1 MM2"],"purpose":["OTC - PURPOSE Earwax removal aid"],"questions":["OTC - QUESTIONS call toll-free 1-866-255-5202 (English/Spanish) weekdays"],"set_id":"dfd2a0a4-0cb6-4e19-addc-b9db2488dcbf","spl_product_data_elements":["DEBROX Carbamide Peroxide CITRIC ACID MONOHYDRATE SODIUM LAUROYL SARCOSINATE SODIUM STANNATE GLYCERIN PROPYLENE GLYCOL WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["SPL UNCLASSIFIED Drug Facts","SPL UNCLASSIFIED 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"],"version":"2","warnings":["WARNINGS 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 avoid contact with the eyes you need to use for more than four days excessive earwax remains after use of this product If swallowed, get medical help or contact a Poison Control Center right away."]}