{"active_ingredient":["Active Ingredient Menthol 5%"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor Wash hands after use with cold water."],"effective_time":"20260430","id":"50b1a42e-f7ee-74db-e063-6294a90a7d89","inactive_ingredient":["Inactive Ingredient: Alcohol, Aloe Vera extract, Arnica Montana Flower extract, Boswellia carteril resin extract, Camellia sinesis leaf extract, Camphor, Carbomer, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex parguariensis leaf extract, Isopropyl myristate, Silica, Triethanolamine, Vitamin E, Water."],"indications_and_usage":["Indications and use Temporarily relieves minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains"],"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"],"package_ndc":["69396-184-01","69396-184-03"],"product_ndc":["69396-184"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["415974"],"spl_id":["50b1a42e-f7ee-74db-e063-6294a90a7d89"],"spl_set_id":["50b1a420-d5cd-6d61-e063-6294a90a0451"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"],"upc":["0850058161501","0850058161495"]},"package_label_principal_display_panel":["Label 4091-FBA Globe Pain Relief Gel-Roll On 2","409103-Globe-menthol-roll-on-3pk-CDER"],"pregnancy_or_breast_feeding":["If Pregnant or breast feeding If Pregnant or breast feeding as a doctor before use."],"purpose":["Purpose Topical Analgesic"],"questions":["Questions? Call 1-888-296-9067"],"set_id":"50b1a420-d5cd-6d61-e063-6294a90a0451","spl_product_data_elements":["Pain Relief Gel Roll On Menthol .ALPHA.-TOCOPHEROL ILEX PARAGUARIENSIS LEAF ARNICA MONTANA FLOWER FD&C YELLOW NO. 5 FD&C BLUE NO. 1 MENTHOL MENTHOL WATER SILICA ALOE BARBADENSIS LEAF JUICE TRIETHANOLAMINE CAMELLIA SINENSIS LEAF OIL ISOPROPYL MYRISTATE FRANKINCENSE CARBOMER CAMPHOR (NATURAL) GLYCERIN"],"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: 4091-FBA"],"stop_use":["Stop Use and Ask Doctor if Stop use and ask doctor if you experience pain, swelling or blistering of the skin if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritic pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age."],"storage_and_handling":["Other Information Store at 20° to 25°C (68° to 77°F) Store in cool dry place away from direct sunlight"],"version":"1","warnings":["Warnings For external use only. Flammable Keep away from excessive heat or open flames."]}