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Lidexa (Xylocaine) Package Insert

Status:
Prescription (Rx) Facts
Strength:
38.8 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) - Lidexa

DESCRIPTION

Lidexa™ (Lidocaine Hydrochloride) Cream 38.8

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.

General

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric Use

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

About this document

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

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Drug information for Lidexa

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 38.8 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the 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
38.8 mg/g – 85 g in 1 bottle, pump NDC 85477-330-07

Source: FDA drug labeling via NLM DailyMed, data as of November 3, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.