^Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
^Description
Lidocaine HCI 2% Jelly is a sterile, aqueous product that contains a local anesthetic agent and is administered topically. (See INDICATIONS for specific uses.)
Lidocaine HCI 2% Jelly contains lidocaine HCI which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride and has the following structural formula:
Its molecular formula is C14H22N2O • HCI and its molecular weight is 270.80.
Lidocaine HCI 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use.
Composition of Lidocaine HCI 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCI. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH between 6.0 to 7.0.
^Overdosage
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
^Do Not Use:
^How Supplied
Lidocaine HCI 2% Jelly is supplied in the listed dosage forms.
NDC 17478-840-30 30 mL aluminum tubeNDC 17478-840-05 5 mL aluminum tube
A detachable applicator cone and a key for expressing the contents are included in the 30 mL carton.
^Other Information
^Purpose
First aid to help prevent infection in:
^Indications And Usage
Lidocaine HCI 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
^Maximum Dosage
No more than 600 mg of lidocaine HCI should be given in any 12 hour period.
^Packaging-system Label
^Packaging-system Components Labeling
^Adverse Reactions
Adverse experiences following the administration of lidocaine are similar in nature to those observed in 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:
There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube. (See also WARNINGS and DOSAGE AND ADMINISTRATION.)
^Drug Facts
TRIPLE ANTIBIOTIC OINTMENT - bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
^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 HCI 2% Jelly.
^Sx1 Medicated Post-operative System
Contents:
1 - 2% Lidocaine Hydrochloride Jelly USP, 5.0mL
1 - Mastisol Liquid Adhesive, 2/3mL
1 - Triple Antibiotic Ointment, 0.9g
1 - Staple Removal System (sterile, with gauze)
1 - Wound Closure Strips (sterile, 1/2" x 4")
1 - Adhesive Tape Remover Pad
1 - Cotton Tipped Applicator (sterile, 6")
^Ask A Doctor Before Use:
First aid to help prevent infection in:
^Inactive Ingredients:
Hard Paraffin, Liquid Paraffin, White Soft Paraffin
^Stop Use And Ask A Doctor If
^Warnings
For external use only