displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine Hydrochloride Topical Solution USP contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses.
Each mL contains:
lidocaine hydrochloride USP . . . . . . . . . . ………………………………………………………………………… 40 mg
Methylparaben, Sodium Hydroxide (to adjust pH) in an aqueous solution. NOT FOR INJECTION.
Lidocaine is a local anesthetic chemically designated as 2-(diethylamino)-N-(2,6-dimethyl-phenyl)-acetamide. It has the following structural formula:
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine hydrochloride is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Lidocaine hydrochloride is contraindicated in patients with a known hypersensitivity either to local anesthetics of the amide type or to the components of the topical solution.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS MUST BE IMMEDIATELY AVAILABLE WHEN LOCAL ANESTHETIC AGENTS, SUCH AS LIDOCAINE, ARE ADMINISTERED TO MUCOUS MEMBRANES.
Lidocaine hydrochloride should be used with extreme caution if there is sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS)
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
When lidocaine hydrochloride topical solution 4% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. Dosages should be reduced for children and for elderly and debilitated patients. The maximum dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight. Although the incidence of adverse effects with lidocaine hydrochloride topical solution 4% is quite low, caution should be exercised particularly when employing large volumes since the incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered.
The dosages recommended below are for normal healthy adults:
When used as a spray, or when applied by means of cotton applicators or packs, as when instilled into a cavity, the suggested dosage of lidocaine hydrochloride topical solution is 1-5 mL (40-200 mg of lidocaine hydrochloride), i.e., 0.6-3.0 mg/kg or 0.3-1.5 mg/lb of body weight.
NOTE: The solution may be applied with a sterile swab which is discarded after use and never reused under any circumstances. When spraying, transfer the solution from the original container to an atomizer.
Maximum Recommended Dosages:
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Hydrochloride Topical Solution USP 4%
The 4% topical solution is supplied as a clear, colorless solution.
NDC 0054-3505-47: Bottle of 50 mL
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid freezing.
Distr. by: West-Ward
Eatontown, NJ 07724
Revised July 2016
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4