{"active_ingredient":["Active Ingredient and Purpose . Active ingredient Purpose Carbamide peroxide 6.5%............... Earwax removal aid"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredient </content></content></paragraph></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Carbamide peroxide 6.5%...............</td><td>Earwax removal aid</td></tr></tbody></table>"],"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":"20260326","id":"4df01db0-dba9-6561-e063-6294a90a6d15","inactive_ingredient":["Inactive ingredients glycerin, water"],"indications_and_usage":["Uses For occasional use as an aid to loosen and remove excessive earwax."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M014"],"brand_name":["DoloEar"],"generic_name":["CARBAMIDE PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-506-01"],"product_ndc":["55758-506"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["4df01db0-dba9-6561-e063-6294a90a6d15"],"spl_set_id":["352df636-0469-c33e-e063-6294a90a2224"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"]},"other_safety_information":["Other information Store in a cool dry place do not use if clear seal over dropper is torn, broken, or missing"],"package_label_principal_display_panel":["Principal Display Panel PDP DOLOEAR"],"purpose":["Active ingredient Purpose Carbamide peroxide 6.5%............... Earwax removal aid"],"purpose_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><paragraph><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredient </content></content></paragraph></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Carbamide peroxide 6.5%...............</td><td>Earwax removal aid</td></tr></tbody></table>"],"questions":["Questions or comments? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com"],"set_id":"352df636-0469-c33e-e063-6294a90a2224","spl_product_data_elements":["DoloEar Carbamide Peroxide GLYCERIN WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["DRUG FACTS","Dist. by/ por: PHARMADEL LLC New Castle, DE 19720 +1-866-359-3478 www.pharmadel.com"],"stop_use":["Stop use and ask your doctor if you need to use for more than 4 days excessive earwax remains after use of this product"],"version":"3","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 ear drum recently had ear surgery When using this product avoid contact with the eyes. Stop use and ask your doctor if you need to use for more than 4 days excessive earwax remains after use of this product Keep out of reach of children."],"when_using":["When using this product avoid contact with the eyes."]}