Lidocaine Hydrochloride

Indications

Lidocaine ointment, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

Dosage and administration (summary)

When lidocaine ointment, 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind. Adult A single application should not exceed 5 g of lidocaine ointment, 5%, containing 250 mg of lidocaine base (equivalent chemically to approximately 300 mg of lidocaine hydrochloride). This is roughly equivalent to squeezing a six inch length of ointment from the tube. In a 70 kg adult this dose equals 3.6 mg/kg (1.6 mg/lb) lidocaine base. No more than one-half tube, approximately 17 to 20 g of ointment or 850 to 1000 mg lidocaine base, should be administered in any one day.

Contraindications

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment, 5%.

Warnings and precautions

EXCESSIVE DOSAGE, OR SHORT INTERVALS BETWEEN DOSES, CAN RESULT IN HIGH PLASMA LEVELS AND SERIOUS ADVERSE EFFECTS, PATIENTS SHOULD BE INSTRUCTED TO STRICTLY ADHERE TO THE RECOMMENDED DOSAGE AND ADMINISTRATION GUIDELINES AS SET FORTH IN THIS PACKAGE INSERT. THE MANAGEMENT OF SERIOUS ADVERSE REACTIONS MAY REQUIRE THE USE OF RESUSCITATIVE EQUIPMENT, OXYGEN, AND OTHER RESUSCITATIVE DRUGS.

Storage and supply

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403 513, India Manufactured for: [Glenmark Logo] Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 721-7115 WWW.GLENMARKPHARMA-US.COM January 2020

Source: Lidocaine (Lidocaine) — US FDA prescribing information, 2026-03-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.