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Nuvexa (Xylocaine) Package Insert

Status:
Prescription (Rx) Facts
Strength:
28 mg/g
Brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Nuvexa

DESCRIPTION

Nuvexa™ is a topical gel containing Lidocaine Hydrochloride 28 mg/g (2.8%).

INDICATIONS AND USAGE

Nuvexa™ is indicated for topical analgesia as directed by a healthcare provider.

CONTRAINDICATIONS

Nuvexa™ 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

Nuvexa™ (Lidocaine Hydrochloride 28 mg/g) is supplied as a clear topical gel in a 3.5 oz (100 g) tube.

NDC 85477-0313-07

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Nuvexa

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Amide Local Anesthetic, Antiarrhythmic
Active ingredient Lidocaine 28 mg/g
Dosage form Gel
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) Oncora Pharma, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
28 mg/g – 100 g in 1 bottle, pump NDC 85477-313-07

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.