Description
Lidomax™ is a topical gel containing Lidocaine Hydrochloride 2%, a local anesthetic. It is intended for topical application to intact skin.
Lidomax Gel
FDA Label NDC 85477-304
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 Lidomax (NDC 85477-304). 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, 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
Lidomax™ is indicated for topical analgesia as directed by a healthcare provider.
Warnings
For external use only. Not for ophthalmic use. Avoid contact with eyes. Do not use if allergic to lidocaine or any components of the formulation. Keep out of reach of children.
Dosage And Administration
Apply a thin layer to the affected area 3 to 4 times daily or as directed by a healthcare provider. For external use only.
How Supplied
Lidomax™ (Lidocaine HCl 2%) is supplied as a clear topical gel in a 3 oz (85 g) tube. NDC 85477-304-07
Principal Display Panel
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).
[See USP Controlled Room Temperature].
Keep container tightly closed.
Pdp (Lidomax Gel 1)
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