LIDOCAINE OINTMENT USP, 5%

FOR TOPICAL USE ONLY

id: 62ea90e5-6ed4-4dbc-bea8-4101f40f8db5
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Rx Only

DESCRIPTION

id: d0157071-28cd-419a-936e-c2e40678559c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lidocaine Ointment 5% contains a local anesthetic agent and is administered topically. See
INDICATIONS AND USAGE for specific uses. Lidocaine Ointment 5% contains lidocaine, which is chemically designated as acetamide, 2- (diethylamino) -N-(2,6-dimethylphenyl)-, and has the following structural formula: C₁₄ H₂₂ N₂O M.W. 234.34

Composition of Lidocaine Ointment 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, (lidocaine) 5% in a water miscible ointment vehicle containing polyethylene glycols and peppermint oil.

INDICATIONS AND USAGE

id: 428417c8-7e36-4abe-b4aa-2511f819964e
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: 56f82c33-2d76-4cbb-b366-a2c67b2c73f1
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: 7b1084f5-ebcf-4ab4-a383-f0fe0c64525a
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: 410d6e13-1e0f-48ea-9aed-d4abd083000d
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.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: da553352-cece-4d82-a9f2-84b9c8d4abe6
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: 50908385-bbd1-43bb-a3c5-141f04eac590
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: 08f0f7c9-c1e6-461e-982f-25e7bc13f951
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, and 50.0 g (1 ¾ oz) jar with child-resistant cap.Store at controlled room temperature 20°- 25°C (68°- 77°F). Do not permit to freeze.Manufactured forHi-Tech Pharmacal Co., Inc.Amityville, NY 11701Rev. 933:01 4/12

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – TUBE

id: d8c9abe7-6477-413e-b6d0-af2d8a7d78f3
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

AKORN
NDC 50383-933-35
Lidocaine Ointment USP, 5%
Rx Only
Laminate tube with Child-Resistant Cap
FOR TOPICAL USE ONLY
NET WT 35.44 g (1¼ oz)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – JAR

id: f2bbfc94-f5aa-4489-8567-6cf4c16a5fd9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Hi-Tech
PHARMACAL
NDC 50383-933-55
Lidocaine Ointment USP, 5%

FOR TOPICAL USE ONLY. Rx Only
NET WT 50 g (1¾ oz)