{"active_ingredient":["Active Ingredient Lidocaine 4.0%"],"do_not_use":["Do not use ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened."],"dosage_and_administration":["Directions Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician."],"effective_time":"20251020","id":"78ab2a01-a25d-48fa-9c45-5ade11bb9385","inactive_ingredient":["Inactive Ingredients aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water"],"indications_and_usage":["Use Temporarily es minor 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 800-222-1222 right away."],"openfda":{"application_number":["M017"],"brand_name":["Lidocaine 4% Maximum OTC Strength"],"generic_name":["LIDOCAINE"],"manufacturer_name":["Cardinal Health 107, LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"original_packager_product_ndc":["0536-1202"],"package_ndc":["55154-7813-5"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["55154-7813"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1737778"],"spl_id":["78ab2a01-a25d-48fa-9c45-5ade11bb9385"],"spl_set_id":["975031df-d46d-4098-b1c0-1c0c92b41995"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0055154781350"]},"other_safety_information":["Other safety information Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture."],"package_label_principal_display_panel":["Principal Display Panel NDC 55154-7813-5 LIDOCAINE PATCH 4% MAXIMUM OTC STRENGTH 5 PATCHES 4% bag label"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding ask a health professional before use"],"purpose":["Purpose Topical anesthetic"],"questions":["Questions or comments? Call 1-866-326-1313"],"set_id":"975031df-d46d-4098-b1c0-1c0c92b41995","spl_product_data_elements":["Lidocaine 4% Maximum OTC Strength Lidocaine LIDOCAINE LIDOCAINE DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (300000 MW) POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER"],"spl_unclassified_section":[". *This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercream®. Distributed by: RUGBY® LABORATORIES Undianapolis, IN 46268 Made in China Questions or comments? Call 1-800-616-2471 www.majorpharmaceuticals.com Distributed By: Cardinal Health Dublin, OH 43017 L59206240624 Rev. 12/23 R-153 Re-order No. 371082"],"spl_unclassified_section_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Rev. 12/23</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>R-153</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Re-order No. 371082</paragraph></td></tr></tbody></table>"],"stop_use":["Stop use and consult a doctor ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied."],"version":"2","warnings":["Warnings For external use only. Do not use ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened. When using this product ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and consult a doctor ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied. If pregnant or breastfeeding ask a health professional before use Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away."],"when_using":["When using this product ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch."]}