Gen7T Plus

GEN7T PLUS- lidocaine and menthol patch
Beijing HKKY Medical Tech. Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Gen7T Plus Patch

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What is Gen7T Plus Patch ® ?

This is a topical hydrogel patch consisting of the local anesthetic, lidocaine, and the topical analgesic, menthol.

What is Gen7T Plus Patch ® used for?

This patch is applied topically for use on normal intact skin for the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains. Read the information sheet provided before you start using this medication and each time you get a refill. If you have any questions, please consult your doctor or pharmacist. Inform your doctor if your condition does not improve or if it worsens. The use of this medication shall be used under the supervision of a physician only as it may be used in conjunction with other therapies.

This information may not include all of the information needed to use Gen7T Plus Patch ® safely and effectively.

For Topical Use Only

What are the possible side effects with Gen7T Plus Patch ®

  • Common: itching, redness or flaking of the skin following application (note: the majority of patients experience no significant adverse events following patch application).
  • NOTE: serious side effects are, in general, related to accidental toxicity of medication by applying considerably more than directed by your doctor or pharmacist or by ingesting the contents of the patch or using this patch in conjunction with other lidocaine containing products.
  • Tell your healthcare provider about all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements.
  • Avoid excessive alcohol usage, since it may increase the potential for Central Nervous System (CNS) effects such as dizziness, confusion, lightheadedness and orthostatic hypotension.

This is not a complete list of the possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

Adults and children 12 years and over:

Apply 1 patch to the affected area of intact skin. Gen7T Plus Patch ® should be removed after 12 hours of continuous use and remain off for at least 12 hours.

  1. Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors. Safely discard the remaining unused pieces of cut patches where children and pets cannot reach.
  2. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope.
  3. Apply 1 patch to the affected area so that the patch covers most of the painful area. Apply patch only once during each 24-hr period (12 hours on / 12 hours off).
  4. Remove patch if irritation occurs.

Children under 12 years of age: Consult a doctor

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.

INACTIVE INGREDIENTS

Polyvinyl alcohol, non-crystallizing sorbitol solution, polyacrylic acid, glycerin, carboxymethylcellulose sodium, colloidal silicon dioxide, titanium dioxide, propylene glycol, tartaric acid, magnesium hydroxide, sodium polyacrylate, purified water.

PRESCRIBER INFORMATION

Gen7T Plus Patch ® (Lidocaine 3.5% / Menthol 7%)

DESCRIPTION

Gen7T Plus Patch ® is a prescription topical patch containing 15 articulated patches or 10 articulated patches. Lidocaine is present in a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C 14 H 22 N 2 O. The molecular weight of lidocaine is 234.34 g/mol. Lidocaine has an octanol: water partition ration of 43 at pH 7.4, and has the following structure:

** Lidocaine**

Lidocaine

Menthol is present in a 7% concentration (w/w). The chemical name is (1R,2S,5R)‐2‐isopropyl-5-methylcyclohexanol. The empirical formula for Menthol is C 10 H 20 O with a molecular weight of 156.27 g/mol. Menthol contains colorless, hexangonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. It has a melting point between 31 O C to 36 O C and has the following structure:

** Menthol**

Menthol

Gen7T Plus Patch ® uses an adhesive hydrogel technology containing lidocaine 3.5% and menthol 7%, applied to a flexible woven polyester backing and protected by a plastic film. The protective film is removed prior to application to the skin.

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