{"active_ingredient":["Active Ingredient Lidocaine 4%"],"do_not_use":["Do Not Use More than 1 patch at a time On wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product"],"dosage_and_administration":["Directions Adult and children 12 years of age and over: Clean and dry affected area Remove film from patch and apply to the skin Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Remove patch from teh skin after at most 8-hour application Children under 12 years of age. Consult a doctor"],"effective_time":"20251202","id":"44fa0730-e8db-61d2-e063-6394a90ac928","inactive_ingredient":["Inactive Ingredients Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water."],"indications_and_usage":["For temporary relief of pain"],"keep_out_of_reach_of_children":["Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Pain Relief Gel-Patch"],"generic_name":["LIDOCAINE 4%"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA, LLC."],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["69396-134-15"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["69396-134"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1737778"],"spl_id":["44fa0730-e8db-61d2-e063-6394a90ac928"],"spl_set_id":["12a27ce7-c547-7134-e063-6394a90a94bd"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0860003665725"]},"package_label_principal_display_panel":["4802 Globe Lidocaine Patch 101323 CDER"],"pregnancy_or_breast_feeding":["If Pregnant or Breast-Feeding Ask a health professional before use"],"purpose":["Purpose Topical Anesthetic"],"questions":["Questions or Comments Call 1-888-296-9067"],"set_id":"12a27ce7-c547-7134-e063-6394a90a94bd","spl_product_data_elements":["Pain Relief Gel-Patch Lidocaine 4% POLYACRYLIC ACID (8000 MW) POLYSORBATE 80 TARTARIC ACID METHYLPARABEN SODIUM POLYACRYLATE (8000 MW) TITANIUM DIOXIDE WATER GLYCERIN PROPYLENE GLYCOL LIDOCAINE LIDOCAINE KAOLIN EDETATE SODIUM POVIDONE K90 PROPYLPARABEN DIHYDROXYALUMINUM AMINOACETATE"],"spl_unclassified_section":["Distributed By: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com SKU: 4802"],"stop_use":["Stop use and ask a doctor Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering Condition worsens Symptoms persist for more than 7 days Symptoms clear up and occur again within a few days"],"storage_and_handling":["Other information Store at controlled room temperature 68º-77ºF (20º-25ºC) Avoid storing product in direct sunlight Protect product from excessive moisture"],"version":"3","warnings":["Warnings For External Use Only"],"when_using":["When Using this product Use only as directed Avoid contact with eyes, mucous membranes or rashes Do not bandage tightly"]}