Description
Collavera™ contains Lidocaine Hydrochloride 20 mg/g (2%) in a topical gel base.
Collavera Gel
FDA Label NDC 85477-305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Collavera (NDC 85477-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications and usage, warnings, overdosage, dosage and administration, how supplied, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
Collavera™ is indicated for topical analgesia as directed by a healthcare provider.
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.
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.
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.
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
Principal Display Panel
Pdp
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