{"active_ingredient":["Lidocaine - 4.0%"],"dosage_and_administration":["Adults and children 5 years of age and older: apply to affected area, not more than 3-4 times daily. Children under 5 years of age: ask a doctor."],"effective_time":"20250627","id":"3893cf5b-7ca1-321b-e063-6294a90a9cb5","inactive_ingredient":["Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance."],"indications_and_usage":["Uses Temporarily relieves pain due to: sunburns, burns, insect bites, and itching."],"keep_out_of_reach_of_children":["Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M017"],"brand_name":["Burn Relief Professional Bio-Kool"],"generic_name":["LIDOCAINE - 4%"],"is_original_packager":[true],"manufacturer_name":["Kool-Down Inc."],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["61566-201-04","61566-201-14"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["61566-201"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1421893","2118551"],"spl_id":["3893cf5b-7ca1-321b-e063-6294a90a9cb5"],"spl_set_id":["827e9c69-4706-0ccf-e053-2991aa0aa1c1"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0043399806075"]},"package_label_principal_display_panel":["label image description"],"purpose":["Topical Pain Reliever"],"set_id":"827e9c69-4706-0ccf-e053-2991aa0aa1c1","spl_product_data_elements":["Burn Relief Professional Bio-Kool Lidocaine - 4% ALOE GLYCERIN STEARIC ACID GLYCERYL STEARATE SE ISOPROPYL MYRISTATE DIETHYLENE GLYCOL MONOETHYL ETHER CERESIN POLYSORBATE 80 CARBOXYPOLYMETHYLENE ZINC OXIDE ALLANTOIN ASCORBIC ACID METHYLPARABEN DIAZOLIDINYL UREA PROPYLPARABEN TROLAMINE EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE ALMOND OIL LIDOCAINE LIDOCAINE"],"version":"3","warnings":["For external use only. Do not use in large quantities, particularity over raw surfaces or blistered areas When using this product keep out of eyes, use only as directed Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days."]}