{"active_ingredient":["Active ingredient Lidocaine 4%"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor"],"effective_time":"20251114","id":"4391728b-dfe1-3ffb-e063-6394a90a240e","inactive_ingredient":["Inactive ingredients Benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate"],"indications_and_usage":["Use for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations"],"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":["Lidocaine"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Marlex Pharmaceuticals Inc"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["10135-672-96","10135-672-99"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["10135-672"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1421893"],"spl_id":["4391728b-dfe1-3ffb-e063-6394a90a240e"],"spl_set_id":["4de2bc60-dc4a-4417-984f-eabab0e926a6"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Lidocaine 4% Topical Anesthetic Cream Pain & Itch Relief Cream NET WT. 0.5 oz.(15g) 672-96","PRINCIPAL DISPLAY PANEL - 30 g Tube Carton Lidocaine 4% Topical Anesthetic Cream Pain & Itch Relief Cream NET WT. (30g) 672-99"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain & Itch Relief"],"safe_handling_warning":["Other information May be applied under occlusive dressing store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)"],"set_id":"4de2bc60-dc4a-4417-984f-eabab0e926a6","spl_product_data_elements":["Lidocaine Lidocaine BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CHOLESTEROL HYDROGENATED SOYBEAN LECITHIN POLYSORBATE 80 PROPYLENE GLYCOL ALPHA-TOCOPHEROL ACETATE TROLAMINE WATER LIDOCAINE LIDOCAINE"],"spl_unclassified_section":["LIDOCAINE 4%- lidocaine cream Marlex Pharmaceuticals, Inc. 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. ---------- Lidocaine 4% Topical Drug Facts"],"stop_use":["Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days rash or irritation develops, persists, or increases"],"version":"7","warnings":["Warnings For external use only. Avoid contact with eyes. Not for prolonged use. Do not use in large quantities, particularly over raw surfaces or blistered areas. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occurs again within a few days rash or irritation develops, persists, or increases If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away"]}