{"active_ingredient":["Lidocaine HCl 4% Back"],"ask_doctor":["Ask a doctor before use if you have ear drainage, discharge, bleeding, fever, sudden hearing loss, dizziness, or ringing in the ears"],"do_not_use":["Do not use if the eardrum is perforated or ruptured if you have ear tubes if you are allergic to lidocaine or any ingredient in this product"],"dosage_and_administration":["Directions Adults and children 6 years and older: place 3 to 5 drops into affected ear up to 4 times daily. Keep head tilted for 2 to 3 minutes after application. Children under 6 years: ask a doctor."],"effective_time":"20260722","id":"5738eafd-9d54-779c-e063-6294a90a77cf","inactive_ingredient":["Inactive ingredients Alcohol USP, Organic Apple Cider Vinegar, Echinacea (Echinacea purpurea) Extract, Goldenseal (Hydrastis canadensis) Root Extract."],"indications_and_usage":["Uses Temporarily relieves ear discomfort and minor pain associated with swimmer's ear, ear canal irritation, and post-irrigation soreness."],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, contact a Poison Control Center right away at 1-800-222-1222."],"openfda":{"application_number":["M014"],"brand_name":["EarBalance Ear Pain Drops"],"generic_name":["LIDOCAINE HYDROCHLORIDE OTIC SOLUTION"],"is_original_packager":[true],"manufacturer_name":["Marie's Original Formulas LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["87541-896-34"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["87541-896"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"spl_id":["5738eafd-9d54-779c-e063-6294a90a77cf"],"spl_set_id":["55057e1b-b11e-51b9-e063-6394a90a9fca"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["Principal Display Panel EarBalance by Marie Originals Ear Pain Drops Kids Ear Pain Relief With 4% Lidocaine HCl + Botanical Extracts Fast-Acting Relief pH-Balanced Ingredients Gentle for Kids' Ears Net 0.5 fl oz (14 mL) Front"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use"],"purpose":["Purpose Local anesthetic"],"set_id":"55057e1b-b11e-51b9-e063-6394a90a9fca","spl_product_data_elements":["EarBalance Ear Pain Drops Lidocaine Hydrochloride Otic Solution LIDOCAINE LIDOCAINE ALCOHOL ECHINACEA PURPUREA HYDRASTIS CANADENSIS WHOLE ACETIC ACID"],"stop_use":["Stop use and ask a doctor pain worsens or lasts longer than 48 hours irritation, redness, or allergic reaction occurs symptoms occur with fever or discharge"],"version":"2","warnings":["Warnings For use in the ear canal only."],"when_using":["When using this product use only in the ear canal avoid contact with eyes do not swallow temporary numbness may occur"]}