{"description":["DESCRIPTION Collavera™ contains Lidocaine Hydrochloride 20 mg/g (2%) in a topical gel base."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION For topical use only. Apply a thin layer to the affected area 3 to 4 times daily or as directed by a healthcare provider. Avoid contact with eyes and mucous membranes."],"effective_time":"20260227","how_supplied":["HOW SUPPLIED Collavera™ (Lidocaine Hydrochloride 20 mg/g) is supplied as a clear topical gel in a 1 oz (28.33 g) tube. NDC 85477-305-07"],"id":"3c0b5871-ff1e-4532-a0de-e378b009e7cd","indications_and_usage":["INDICATIONS AND USAGE Collavera™ is indicated for topical analgesia as directed by a healthcare provider."],"openfda":{"brand_name":["Collavera"],"generic_name":["COLLAVERA"],"is_original_packager":[true],"manufacturer_name":["Oncora Pharma, LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["85477-305-07"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["85477-305"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["1011852"],"spl_id":["3c0b5871-ff1e-4532-a0de-e378b009e7cd"],"spl_set_id":["88b9fa02-40a7-4fe6-87b8-6787061f5b92"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0854770305076"]},"overdosage":["OVERDOSAGE Excessive topical application may increase systemic absorption of lidocaine and may result in central nervous system and cardiovascular effects. In the event of overdose, discontinue use and seek medical attention."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL pdp pdp"],"set_id":"88b9fa02-40a7-4fe6-87b8-6787061f5b92","spl_product_data_elements":["Collavera Collavera LIDOCAINE LIDOCAINE WATER HYDROXYETHYLCELLULOSE MARINE COLLAGEN, SOLUBLE PHENOXYETHANOL ALOE BARBADENSIS LEAF ETHYLHEXYLGLYCERIN SODIUM HYDROXIDE LACTIC ACID"],"version":"1","warnings":["WARNINGS For external use only. Not for ophthalmic use. Avoid contact with eyes. Excessive application may result in systemic absorption. Use only as directed. Keep out of reach of children."]}