Lidexa by Oncora Pharma, LLC LIDEXA cream

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
PRINCIPAL DISPLAY PANEL

pdp

INGREDIENTS AND APPEARANCE

LIDEXA
lidexa cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	38.8 mg in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 85477-330-07	85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/26/2026

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/26/2026

Labeler - Oncora Pharma, LLC (119482542)

Lidexa by