{"active_ingredient":["Active ingredient Lidocaine 3% (3g in 100g)"],"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: do not use, consult a doctor."],"effective_time":"20250612","id":"029f4902-bc3a-4fd9-8b5e-388d8ae9cf61","inactive_ingredient":["Inactive ingredients acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate."],"indications_and_usage":["Uses for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations"],"keep_out_of_reach_of_children":["Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M017"],"brand_name":["Lidocaine"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Stratus Pharmaceuticals Inc"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["58980-826-30","58980-826-85"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["58980-826"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2049533"],"spl_id":["029f4902-bc3a-4fd9-8b5e-388d8ae9cf61"],"spl_set_id":["5eb6574c-2066-4390-befc-8e5d2dd6ede2"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 85 g Tube Box STRATUS PHARMACEUTICALS INC NDC 58980-826-85 Net WT. 3 oz. / 85 g LIDOCAINE CREAM 3% PAIN RELIEVING CREAM FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE PRINCIPAL DISPLAY PANEL - 85 g Tube Box"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding Ask a health professional before use."],"purpose":["Purpose Local analgesic"],"questions":["Questions? Call us at (800) 442-7882"],"set_id":"5eb6574c-2066-4390-befc-8e5d2dd6ede2","spl_product_data_elements":["Lidocaine Lidocaine Lidocaine Lidocaine Acrylamide CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) Allantoin ALOE VERA LEAF Benzyl Alcohol ALKYL (C12-15) BENZOATE ISOHEXADECANE Polysorbate 80 Propylene Glycol WATER SODIUM ACRYLOYLDIMETHYLTAURATE SODIUM LAURETH-3 SULFATE SOYBEAN LECITHIN .ALPHA.-TOCOPHEROL ACETATE"],"spl_unclassified_section":["Drug Facts","Distributed by: Stratus Pharmaceuticals Inc. Miami, FL 33186"],"stop_use":["Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days"],"storage_and_handling":["Other information Store at 20°C to 25°C (68°F to 77°F)"],"version":"2","warnings":["Warnings For external use only When using this product avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use. If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately."],"when_using":["When using this product avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas"]}