{"active_ingredient":["Active Ingredient Lidocaine 4%","Active Ingredient Menthol 1%"],"dosage_and_administration":["Directions Adults and children over 12 years: apply to the affected area not more than 3 to 4 times daily. Children 12 years or younger: ask a doctor After applying wash hands with soap and water"],"effective_time":"20260513","id":"51b417b7-d5f6-efad-e063-6394a90afc23","inactive_ingredient":["Inactive Ingredient: Aloe Vera Extract, Carbomer, Isopropyl Myristate, Lavender oil, Phenoxyethanol, Polysorbate 80, Propylene glycol, Tartaric Acid, Vitamin E, Water"],"indications_and_usage":["Indications and use Temporarily relieves 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":["Pain Relief Gel-Roll On"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["69396-185-01","69396-185-03"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["69396-185"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1804176"],"spl_id":["51b417b7-d5f6-efad-e063-6394a90afc23"],"spl_set_id":["51b403dc-fc9b-0cad-e063-6394a90af081"],"substance_name":["LIDOCAINE","MENTHOL"],"unii":["98PI200987","L7T10EIP3A"],"upc":["0850058161525","0850058161518"]},"package_label_principal_display_panel":["4092-FBA Globe Fast-Acting Pain Relief Gel Roll On 2","Label 409203 4 percent Lidocaine 1 percent Menthol roll-on 3PK"],"pregnancy_or_breast_feeding":["If Pregnant or breast feeding If Pregnant or breast feeding as a doctor before use."],"purpose":["Purpose Topical Analgesic","Purpose Topical Analgesic"],"questions":["Questions? Call 1-888-296-9067"],"set_id":"51b403dc-fc9b-0cad-e063-6394a90af081","spl_product_data_elements":["Pain Relief Gel-Roll On Menthol TARTARIC ACID LIDOCAINE LIDOCAINE LAVENDER OIL MENTHOL MENTHOL POLYSORBATE 80 .ALPHA.-TOCOPHEROL WATER ALOE BARBADENSIS LEAF JUICE CARBOMER ISOPROPYL MYRISTATE PROPYLENE GLYCOL PHENOXYETHANOL"],"spl_unclassified_section":["DRUG FACTS","Distributed By: Trifecta Pharmaceuticals USA ® 101 NE Third Avenue, Suite 1500 Fort Lauderdale, FL. 33301 USA www.trifecta-pharma.com SKU: 4092-FBA"],"stop_use":["Stop Use and Ask Doctor if Stop use and ask doctor if Condition worsens severe burning sensation, redness, rash or irritation deveolps symptoms persisit 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":["Other Information Store at 20° to 25°C (68° to 77°F)"],"version":"1","warnings":["Warnings For external use only. Flammable Keep away from excessive heat or flame."]}