{"active_ingredient":["Active ingredient Lidocaine 5% w/w"],"dosage_and_administration":["DIRECTIONS When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor."],"effective_time":"20260507","id":"155520b3-0b6a-4267-a60e-8a1d3615a1c6","inactive_ingredient":["INACTIVE INGREDIENTS Stearic Acid,Magnesium Sulfate Unspecified, Laureth,Isopropyl Myristate,C13-14 Isoprraffin, Sunflower Oil,Glycyrrhiza Glabra,Paraguay holly extract,Phenoxyethanol,Glyceryl-Steatate, Polyacrylamide,Lemon oil,Water,Peppermint oil."],"indications_and_usage":["Uses For the temporary relief of local pain, soreness, burning, itching or discomfort associated with anorectal disorders."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Lidocaine 5% Cream"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Medcore LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["82461-420-30"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["82461-420"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1366789"],"spl_id":["155520b3-0b6a-4267-a60e-8a1d3615a1c6"],"spl_set_id":["15d02b42-bf8b-486a-a081-f6d17cc11ec7"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC: 82461-420-30 Lidocaine 5% Topical Anesthetic Anorectal Cream Medcore LLC 30 gram lidocaine lidocaine"],"purpose":["Purpose Topical anesthetic"],"set_id":"15d02b42-bf8b-486a-a081-f6d17cc11ec7","spl_product_data_elements":["Lidocaine 5% Cream Lidocaine LIDOCAINE LIDOCAINE STEARIC ACID GLYCERYL 1-STEARATE MAGNESIUM SULFATE, UNSPECIFIED FORM ISOPROPYL MYRISTATE SUNFLOWER OIL GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER LAURETH-7 ILEX PARAGUARIENSIS LEAF LEMON OIL, COLD PRESSED PEPPERMINT OIL C13-14 ISOPARAFFIN PHENOXYETHANOL POLYACRYLAMIDE (10000 MW) WATER"],"spl_unclassified_section":["Drug Facts","Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days if pregnant or breastfeeding","Manufactured For: Medcore LLC 3048 Valley Rd. Basking Ridge, NJ 07920 Questions or Comments Please call 908-280-2269"],"storage_and_handling":["OTHER INFORMATION Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature."],"version":"1","warnings":["Warnings For external use only. When using this product avoid contact with eyes do not exceed recommended daily dosage unless directed by a physician do not put this product into the rectum by using fingers or any mechanical device or applicator. in case of bleeding, consult a doctor promptly"]}