Description
Lidexa™ (Lidocaine Hydrochloride) Cream 38.8
Lidexa Cream
FDA Label NDC 85477-330
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 Lidexa (NDC 85477-330). 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, precautions, adverse reactions, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
Lidexa™ is indicated for topical analgesia as directed by a healthcare provider.
Contraindications
Lidexa™ 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.
Precautions
Use only as directed. If irritation occurs, discontinue use and consult a healthcare provider.
Adverse Reactions
Localized skin reactions such as redness, irritation, or rash may occur.
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
Lidexa™ (Lidocaine Hydrochloride 38.8 mg/g) is supplied as a white topical cream in a 3 oz (85 g) tube.
NDC 85477-330-07
Principal Display Panel
Pdp
* Please review the disclaimer below.
