{"active_ingredient":["Active Ingredient Carbamide Peroxide 6.5%...........Earwax removal aid"],"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 soft ruber bulb ear syringe. Children under 12 years of age: consult a doctor."],"effective_time":"20250722","id":"3a8ad090-e1c6-7ea7-e063-6394a90a6ffc","inactive_ingredient":["Inactive ingredients Cajeput oil, camphor, eucalyptus oil, glycerin, menthol, methlyparaben, phosphoric acid, polysorbate 20, propylene glycol, 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 out of reach of children."],"openfda":{"application_number":["M014"],"brand_name":["Auralyt"],"generic_name":["CARBAMIDE PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["Menper Distributors, Inc"],"package_ndc":["53145-311-04"],"product_ndc":["53145-311"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["3a8ad090-e1c6-7ea7-e063-6394a90a6ffc"],"spl_set_id":["95920b87-941f-48cb-850c-40d2735596d4"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"],"upc":["0042279104010"]},"other_safety_information":["Other information Store this product between 15° to 30° C (59°-86° F) Tamper-Evident Feature: Do not use this product if imprinted safety seal over bottle cap is torn, broken, or missing"],"package_label_principal_display_panel":["label"],"pregnancy_or_breast_feeding":["if pregnate or breast-feeding ask a health professional before use. In case of accidental indegestion, get medical help or contact a Poison Control Center right away."],"purpose":["Purpose Earwax removal aid"],"questions":["Questions or comments? 1-800-560-5223 M-F from 9 AM to 4 PM Eastern."],"set_id":"95920b87-941f-48cb-850c-40d2735596d4","spl_product_data_elements":["Auralyt Carbamide Peroxide CAJUPUT OIL CAMPHOR (NATURAL) EUCALYPTUS OIL GLYCERIN MENTHOL METHYLPARABEN PHOSPHORIC ACID POLYSORBATE 20 PROPYLENE GLYCOL SODIUM STANNATE WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"version":"5","warnings":["AVOID CONTACT WITH EYES Do not use : if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor."]}