Description
Lidovara™ is a topical gel containing Lidocaine Hydrochloride 28 mg/g (2.8%).
Lidovara Gel
FDA Label NDC 85477-303
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 Lidovara (NDC 85477-303). 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, contraindications, 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
Lidovara™ is indicated for topical analgesia as directed by a healthcare provider.
Contraindications
Lidovara™ is contraindicated in patients with known hypersensitivity to lidocaine or any component of the formulation.
Warnings
For external use only. Not for ophthalmic use.
Avoid contact with eyes.
Excessive application may result in increased systemic absorption.
Keep out of reach of children.
Overdosage
Excessive topical application may result in increased systemic absorption of lidocaine. In the event of overdose, discontinue use and seek medical attention.
Dosage And Administration
For topical use only.
Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.
How Supplied
Lidovara™ (Lidocaine Hydrochloride 28 mg/g) is supplied as a clear topical gel in a 3.5 oz (100 g) tube.
NDC 85477-303-07
Principal Display Panel
Pdp
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