Gen7T Plus

CONTRAINDICATIONS Gen7T Plus Patch ® is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the topical amide-like local anesthetic preparations or to any other component of the product.

WARNINGS FOR EXTERNAL USE ONLY 1. Do not use : More than 1 patch on your body at a time or on irritated or swollen skin On wounds, damaged or infected skin On eyes, mouth, genitals, or other mucous membranes With a heating pad 2. Consult physician for children under 12 years of age 3. Stop and consult your prescriber If condition or pain worsens If you are allergic to any of the ingredients in this product If using concurrently with any other external pain-relieving products If you are pregnant, planning to become pregnant, or breastfeeding If symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: Shortness of breath Swelling or numbness of the tongue or throat Severe headache or vomiting Dizziness or faintness Changes in vision or speech Excessive dosage, or short interval 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 set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. General information about the safe and effective use Gen7T Plus Patch ® Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication unless instructed and prescribed by a physician. Do not give this drug to anyone else, even if they have the same condition. This product is intended for use as prescribed by a physician. How should I store Gen7T Plus Patch ® Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Safely discard product after expiration date posted on the product label. Discard patches away from small children or animals. DO NOT use the product after the expiration date printed on the box. What are the active ingredients in Gen7T Plus Patch ® ? The patch consists of 3.5% lidocaine and 7% menthol.

DRUG INTERACTIONS Antiarrhythmic Drugs: Gen7T Plus Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Gen7T Plus Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.

ADVERSE REACTIONS The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of Gen7T Plus Patch ® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

PREGNANCY: The safety of Gen7T Plus Patch ® has not been established during pregnancy. There are no well-controlled studies in pregnant women. Gen7T Plus Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician.