DESCRIPTION
id: 914c80c8-75da-4af9-a16a-1e088009498c
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, USP, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula:
Composition of lidocaine ointment USP, 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, (lidocaine, USP) 5% in a water miscible ointment vehicle containing polyethylene glycols.
INDICATIONS AND USAGE
id: 934f1da1-59c9-4b41-955c-10a4e8cd655f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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.
CONTRAINDICATIONS
id: 5895dab6-b75c-4036-82d4-3730dbc84bab
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, 5%.
WARNINGS
id: 0339faa0-8424-4c1f-bd40-beeb06b96f91
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, 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.
ADVERSE REACTIONS
id: 4fd39c0a-3cd4-4574-b362-57b6e74a7990
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:
OVERDOSAGE
id: 6b13be64-a098-47b1-954f-a49bb74602c5
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 ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).
DOSAGE AND ADMINISTRATION
id: 3d3b5ec7-0bf2-46f1-ad4c-e2a25d2a886d
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
When lidocaine ointment, 5% is used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
HOW SUPPLIED
id: c632daba-81a2-40bb-a01f-45dc5509ae56
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Lidocaine Ointment USP, 5% is available in 35.44 g (1¼ oz) laminate tubes with a child-resistant cap (NDC 68462-418-20) and 50 g jar (NDC 68462-418-27).
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Manufactured by:
Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa
June 2018
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
id: 8328b972-1bea-4903-8099-0a88f60d26df
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
id: 30bdeb4b-2fd4-4a63-bc09-39d31376f9ea
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
