{"active_ingredient":["ACTIVE INGREDIENT Carbamide Peroxide USP 6.5%"],"dosage_and_administration":["DIRECTIONS FOR USE IN THE EAR ONLY. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the 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 an ear irrigation system."],"effective_time":"20211112","id":"7de540a2-28f8-41fc-bf5e-289f520fec16","inactive_ingredient":["INACTIVE INGREDIENTS Glycerin, Propylene Glycol, Sodium Bicarbonate, Lactic Acid, Purified 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)."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label EARCLEAR Rx™ EAR WAX REMOVAL DROPS Active ingredients: Carbamide Peroxide USP 6.5% 0.5 FL OZ (15 mL) NDC: 74318-102-05 PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label"],"purpose":["For occasional use as an aid to soften, loosen, and remove excessive earwax."],"questions":["Question or Comments (760) 362-8411"],"set_id":"8fa15a59-fb7b-4c88-a61d-0cf977a6e834","spl_product_data_elements":["EarClearRx CARBAMIDE PEROXIDE CARBAMIDE PEROXIDE HYDROGEN PEROXIDE GLYCERIN PROPYLENE GLYCOL WATER SODIUM BICARBONATE LACTIC ACID, UNSPECIFIED FORM"],"spl_unclassified_section":["Children under 12 years of age: consult a doctor before use.","Distributed by: Nuance Medical LLC"],"storage_and_handling":["Other information Do not store above 25°C (77°F)."],"version":"1","warnings":["WARNINGS Ask a doctor before use if you have ear drainage, discharge, ear pain, irritation or rash in the ear, dizziness, had an injury or perforation of the ear drum. 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. 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)."]}