displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Lidocaine Ointment USP, 5% contains a local anesthetic agent and is administered topically. See
INDICATIONS AND USAGE
for specific uses.
Lidocaine Ointment USP, 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula:
Composition of Lidocaine Ointment USP, 5%: Each gram contains lidocaine USP, 5% in a water soluble base containing polyethylene glycol 400, polyethylene glycol 3350, and propylene glycol.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lidocaine Ointment USP, 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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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 USP, 5%.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
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.
Lidocaine Ointment USP, 5% should be used with extreme caution in the presence of 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 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: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics. (See
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
When Lidocaine Ointment USP, 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Ointment USP, 5% is available in:
30 g tubes with a child resistant cap (NDC 51672-3020-2)
35.44 g tubes with a child resistant cap (NDC 51672-3020-9)
PRINCIPAL DISPLAY PANEL – 30 g Tube Carton
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Ointment USP, 5%
CHILD RESISTANT CAP.
DO NOT USE IN THE EYES.
Keep this and all medications out of the reach of children.