{"active_ingredient":["Active Ingredient Lidocaine 4% w/w"],"do_not_use":["Do not use in or near the eyes in large quantities, particularly over raw or blistered areas"],"dosage_and_administration":["Directions Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age: Consult a doctor."],"effective_time":"20241231","how_supplied":["How Supplied/Storage and Handling Lidocaine 4% Cream is supplied in: 15g tube NDC: 80425-0351-01 Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature]."],"id":"2a9c0c91-2b38-4def-e063-6294a90a58ef","inactive_ingredient":["Inactive ingredients Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate."],"indications_and_usage":["Uses temporarily relieves pain and itching due to minor cuts minor scrapes minor burns sunburn minor skin irritation insect bites"],"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"],"generic_name":["LIDOCAINE"],"manufacturer_name":["Advanced Rx Pharmacy of Tennessee, LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"original_packager_product_ndc":["39328-024"],"package_ndc":["80425-0351-1"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["80425-0351"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1421893"],"spl_id":["2a9c0c91-2b38-4def-e063-6294a90a58ef"],"spl_set_id":["01cb19a4-ce22-144d-e063-6294a90a8aa3"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["label 1"],"purpose":["Purpose Topical anesthetic"],"questions":["Questions? Call 800-936-3088"],"set_id":"01cb19a4-ce22-144d-e063-6294a90a8aa3","spl_product_data_elements":["Lidocaine Lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) HYDROGENATED SOYBEAN LECITHIN POLYSORBATE 80 PROPYLENE GLYCOL WATER TROLAMINE .ALPHA.-TOCOPHEROL ACETATE LIDOCAINE LIDOCAINE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase"],"storage_and_handling":["Other Information May be applied under occlusive dressing. Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature]."],"version":"2","warnings":["Warnings For external use only. Do not use in or near the eyes in large quantities, particularly over raw or blistered areas Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}