{"active_ingredient":["Active ingredients Lidocaine HCl 2.0%"],"do_not_use":["Do not use in large quantities, particularly over raw or blistered areas near eyes, if this happens rinse thoroughly with water Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns"],"dosage_and_administration":["Directions for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily for children under 2 years of age consult a physician"],"effective_time":"20240207","id":"114b1a82-0728-fe2e-e063-6394a90a309e","inactive_ingredient":["Inactive ingredients aloe vera, germaben II, propylene glycol, purified water Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com PAIN RELIEF – Burn Spray Safetec of America Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ----------"],"indications_and_usage":["Uses Temporary pain relief for minor burns"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away"],"openfda":{"application_number":["M017"],"brand_name":["Lidocaine Hydrochloride"],"generic_name":["LIDOCAINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Safetec of America, Inc."],"package_ndc":["61010-5100-4","61010-5100-5"],"product_ndc":["61010-5100"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1010769"],"spl_id":["114b1a82-0728-fe2e-e063-6394a90a309e"],"spl_set_id":["8eb3e7e2-26e5-430e-89aa-40a0367c637e"],"substance_name":["LIDOCAINE HYDROCHLORIDE"],"unii":["V13007Z41A"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL – 3 oz. bottle NDC 61010-5100-3 Safetec First Aid Burn Spray For Temporary Pain Relief of Minor Burns 3 fl. oz. (88.7 ml) Reorder no. 50104 PRINCIPAL DISPLAY PANEL – 3 oz. bottle","PRINCIPAL DISPLAY PANEL – 2 oz. bottle NDC 61010-5100-4 Safetec First Aid Burn Spray For Temporary Pain Relief of Minor Burns 2 fl. oz. (59.1 ml) Reorder no. 50004 PRINCIPAL DISPLAY PANEL – 2 oz. bottle","PRINCIPAL DISPLAY PANEL – 4 oz. bottle NDC 61010-5100-5 Safetec First Aid Burn Spray For Temporary Pain Relief of Minor Burns 4 fl. oz. (118 ml) Reorder no. 50005 PRINCIPAL DISPLAY PANEL – 4 oz. bottle"],"purpose":["Purpose Topical pain relief"],"set_id":"8eb3e7e2-26e5-430e-89aa-40a0367c637e","spl_product_data_elements":["Lidocaine Hydrochloride Lidocaine Hydrochloride ALOE VERA LEAF PROPYLENE GLYCOL DIAZOLIDINYL UREA WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns"],"version":"7","warnings":["Warnings For external use only Do not use in large quantities, particularly over raw or blistered areas near eyes, if this happens rinse thoroughly with water Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away"]}