NDC 70645-628 Gen7t Plus

Lidocaine, Menthol

NDC Product Code 70645-628

NDC 70645-628-35

Package Description: 15 PATCH in 1 BOX

NDC Product Information

Gen7t Plus with NDC 70645-628 is a a human prescription drug product labeled by 7t Pharma Llc. The generic name of Gen7t Plus is lidocaine, menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: 7t Pharma Llc

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Gen7t Plus Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LIDOCAINE 490 mg/1
  • MENTHOL 980 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TARTARIC ACID (UNII: W4888I119H)
  • MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Amide Local Anesthetic - [EPC] (Established Pharmacologic Class)
  • Amides - [CS]
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Local Anesthesia - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: 7t Pharma Llc
Labeler Code: 70645
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Gen7t Plus Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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. 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. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope. 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).Remove patch if irritation occurs. Children under 12 years of age: Consult a doctor

Warnings

  • FOR EXTERNAL USE ONLY1. Do not use: More than 1 patch on your body at a time or on irritated or swollen skinOn wounds, damaged or infected skinOn eyes, mouth, genitals, or other mucous membranesWith a heating pad2. Consult physician for children under 12 years of age3. Stop and consult your prescriberIf condition or pain worsensIf you are allergic to any of the ingredients in this productIf using concurrently with any other external pain-relieving productsIf you are pregnant, planning to become pregnant, or breastfeedingIf symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 daysCall your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:Shortness of breathSwelling or numbness of the tongue or throatSevere headache or vomitingDizziness or faintness Changes in vision or speechExcessive 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 INFORMATIONGen7T Plus Patch® (Lidocaine 3.5% / Menthol 7%)

Description

Gen7T Plus Patch® is a prescription topical patch containing 15 articulated patches (5 per resealable pouch x 3 pouches). 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 C14H22N2O. 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 **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 C10H20O 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 31OC to 36OC and has the following structure: ** 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. The size of the patch is 10cm x 14cm.

Clinical Pharmacology

Lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Menthol has local anesthetic and counterirritant qualities. It also acts as a weak kappa (ĸ) opioid receptor agonist. Menthol chemically triggers the cold-‐sensitive TRPM-8 receptors in the skin, which are responsible for the well-‐documented cooling sensation that occurs when applied to the skin. Menthol’s analgesic properties are not fully understood; however, they are mediated through a selective activation of ĸ-opioid receptors. Menthol also blocks voltage-‐sensitive sodium channels, reducing neural activity that may stimulate muscle tissue.Menthol works by targeting the k-‐opioid receptor on the TRPM8 neuron. The TRPM8 neuron is normally activated at temperatures between (8°-28°C). Menthol causes the neuron to fire at temperatures above normal activation, which triggers the characteristic cooling sensation. Also because of menthol's specific targeting of the k-‐opioid receptor, it is endowed with analgesic properties.Lidocaine is an amide-‐type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses.The penetration of Lidocaine into intact skin after application of patch is sufficient to produce an analgesic effect, but less than the amount necessary to produce a complete sensory block.

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.

Precautions

Because of the possibility of sedation, patients should be cautioned regarding the operation of heavy machinery or automobiles, and any activities made hazardous by decreased alertness.Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine, because of their inability to metabolize Lidocaine normally. Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to Lidocaine. However, this product should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain. Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of Lidocaine from increased absorption. Gen7T Plus Patch® is only recommended for use on intact skin. Eye Exposure: The contact of this product with the eyes, although not studied, should be avoided based on the findings of severe eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over patches is not recommended as this has not been evaluated and may increase plasma Lidocaine levels.

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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of topical lidocaine. The effect of Gen7T Plus Patch® on fertility has not been studied.

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.

Nursing Mothers

The effect of Gen7T Plus Patch® on the nursing infant has not been evaluated. Caution should be exercised when Gen7T Plus Patch® is administered to a nursing mother.

Pediatric / Geriatric Use

Safety and effectiveness in pediatric and geriatric patients have not been established.

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.

Overdosage

There have been no reports of over-dosage with Gen7T Plus Patch®. Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.

How Supplied

Gen7T Plus Patch® is supplied in the following dosage form:15 Patches [ (5 per Re-sealable Pouch) x 3 ] 3 15/16” X 5 1/2" (10 cm X 14 cm)Made in USARx OnlyManufactured for: 7T Pharma, LLC220 Emerald Vista WayLas Vegas, NV 89144800.941.2848NDC: 70645-628-35 Size: 15 Patches

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