{"active_ingredient":["Active Ingredients Lidocaine 4%"],"do_not_use":["Do not use Do not use on raw or blistered skin on the eyes if alergic to lidocaine or any ingredient in the patch more than 4 daily with a heating pad"],"dosage_and_administration":["Directions Adults and children 2 years of age or older: Apply the patch to clean dry skin 60 minutes before procedure Immediately prior to procedure, remove the center of the patch, leaving ring in place to outline treated area Follow usual needle procedure steps Remove ring after procedure Children under 2 years of age: Consult a doctor prior to use"],"effective_time":"20250326","id":"31408e34-cb94-3252-e063-6394a90a99a9","inactive_ingredient":["Inactive Ingredients Acrylic adhesive, Polyethylene film, Mylar release liner, Polyethylene Glycol, Levulinic acid, BrijL4LQ, Isopropyl Palmitate"],"indications_and_usage":["Uses For the temporary relief of pain."],"keep_out_of_reach_of_children":["Keep out of reach of children and pets If swallowed get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M017"],"brand_name":["Achelon Lidocaine Patch"],"generic_name":["LIDOCAINE PATCH 4%"],"is_original_packager":[true],"manufacturer_name":["Achelon, Inc"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["84209-400-01"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["84209-400"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1737778"],"spl_id":["31408e34-cb94-3252-e063-6394a90a99a9"],"spl_set_id":["31408e21-e58d-6db5-e063-6294a90aa4bc"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"other_safety_information":["Other information store at 68 o - 77 o F (20 o - 25 o C)"],"package_label_principal_display_panel":["Achelon Lidocaine 4%, One Patch in Indivdual Pouch Achelon Front Drug Facts Panel"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding ask a health professional before use."],"purpose":["Purpose Topical Analgesic"],"set_id":"31408e21-e58d-6db5-e063-6294a90aa4bc","spl_product_data_elements":["Achelon Lidocaine Patch Lidocaine Patch 4% LIDOCAINE LIDOCAINE LEVULINIC ACID POLYETHYLENE GLYCOL 400 ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) ISOPROPYL PALMITATE"],"stop_use":["Stop use or ask a doctor if If you develop a rash or skin irritation"],"version":"1","warnings":["Warnings For external use only."],"when_using":["When using this product Use only as directed Do not inject through any patch material"]}