{"active_ingredient":["Lidocaine 4% Topical Anesthetic Menthol 1% Topical Anesthetic"],"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 Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard after single use. Children under 12 years of age: consult a physician."],"effective_time":"20251228","id":"47061346-aa5f-1a85-e063-6294a90afd0a","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":["USES Temporary relief of minor pain"],"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":["Point Relief LidoSpot with Menthol"],"generic_name":["LIDOCAINE, MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Fabrication Enterprises"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["51452-912-05"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["51452-912"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1249758"],"spl_id":["47061346-aa5f-1a85-e063-6294a90afd0a"],"spl_set_id":["f0c69693-bfea-4006-9620-63b222d25d38"],"substance_name":["LIDOCAINE","MENTHOL, UNSPECIFIED FORM"],"unii":["98PI200987","L7T10EIP3A"]},"package_label_principal_display_panel":["Manufactured For: Fabrication Enterprises Inc White Plains, NY 10602 www.FabEnt.com LidoSpot with Menthol"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding Contact a physician prior to use."],"purpose":["Topical Anesthetic"],"set_id":"f0c69693-bfea-4006-9620-63b222d25d38","spl_product_data_elements":["Point Relief LidoSpot with Menthol Lidocaine, Menthol DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS GLYCERIN KAOLIN METHYLPARABEN POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) PROPYLPARABEN POVIDONE, UNSPECIFIED SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE WATER LIDOCAINE LIDOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and consult a doctor if ■ 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."],"storage_and_handling":["Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture."],"version":"3","warnings":["WARNINGS For External use only. Use only as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. ■ 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. If pregnant or breast feeding Contact a physician prior to use. WHEN USING: ■ 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 if ■ 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."],"when_using":["WHEN USING: ■ 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."]}