Tranzarel Gel

TRANZAREL 4% is comprised of a topical anesthetic that is indicated for relief of minor pain.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:

Each gram contains 40 mg of lidocaine in an aqueous gel base. It also contains the following inactive ingredients: Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine.

TRANZAREL 4% is comprised of a topical anesthetic that is indicated for relief of minor pain.

TRANZAREL is contraindicated in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics. If excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician.

Apply TRANZAREL to affected area(s) of pain three to four times a day or as directed by a physician. TRANZAREL should only be applied to intact skin. The cap and foil should be removed from the tube prior to use.

To open tube: Turn cap, push down, turn and lift off.
To close tube: Turn on cap until it locks into place.

May be applied under occlusive dressing. Consult with your physician first.

TRANZAREL (Lidocaine) 4% Pain Relieving Gel is available as the following:

4 fl. oz. (120 mL) laminate tube with a child-resistant cap, NDC 70877-2324-4

Store at 25°C (77°F); excursions permitted: 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]

Manufactured for:
Taleos Pharma Corp.
Eatontown, NJ 07724

Tranzarel and TALEOS are trademarks of Taleos Pharma Corp.

Applies to lidocaine topical: topical application aerosol liquid, topical application cream, topical application dressing, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray

Along with its needed effects, lidocaine topical (the active ingredient contained in Tranzarel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

• Blistering, crusting, irritation, itching, or reddening of the skin
• cough
• cracked, dry, or scaly skin
• fast heartbeat
• fever
• hives or welts, itching, or skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

• Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
• blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness or dizziness
• false or unusual sense of well-being
• fear or nervousness
• irregular, fast or slow, or shallow breathing
• lethargy
• no blood pressure or pulse
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• slow or irregular heartbeat
• stopping of heart
• trembling or shaking of the hands or feet
• twitching
• unconsciousness
• unusual tiredness or weakness
• weakness

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• cold or numbness
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• double vision
• headache
• hearing loss
• heat sensation
• lack or loss of strength
• metallic taste
• sleepiness or unusual drowsiness