NDC 71073-201 Limencin

Lidocaine And Menthol

NDC Product Code 71073-201

NDC CODE: 71073-201

Proprietary Name: Limencin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Lidocaine And Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to relieve nerve pain after shingles (infection with the herpes zoster virus). This type of pain is called post-herpetic neuralgia. Lidocaine helps to reduce sharp/burning/aching pain as well as discomfort caused by skin areas that are overly sensitive to touch. Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

NDC Code Structure

  • 71073 - Beijing Hkky Medical Tech. Co., Ltd.

NDC 71073-201-01

Package Description: 2 POUCH in 1 CARTON > 5 PATCH in 1 POUCH

NDC Product Information

Limencin with NDC 71073-201 is a a human over the counter drug product labeled by Beijing Hkky Medical Tech. Co., Ltd.. The generic name of Limencin is lidocaine and menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Beijing Hkky Medical Tech. Co., Ltd.

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 Otc 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.

Limencin 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 40 mg/1
  • MENTHOL, UNSPECIFIED FORM 40 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • LEMON PEEL (UNII: 72O054U628)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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

Product Labeler Information

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

Labeler Name: Beijing Hkky Medical Tech. Co., Ltd.
Labeler Code: 71073
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-15-2019 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.

Limencin Product Label Images

Limencin 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

Active Ingredients:

Menthol 4%

Lidocaine 4%

Purpose

Topical Analgesic

Topical Anesthetic

Uses:

For the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Warnings:

  • Only for external use. Use only as directed or by a health professional.
  • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucus membranes.
  • Do not cover with bandage.
  • Keep out of reach of children. Consult physician for children under 12.
  • Consult your physician: if pregnant or pain persists or worsens.

Directions:

  • Adults and children 12 years and over: Apply patch to affected area 1 to 2 times daily or as directed. Instruction for Use: Clean and dry the affected area
  • Open pouch and remove one patch
  • Remove any protective film and apply directly to affected area of pain
  • Wash hands with soap and water after applying patch
  • Reseal pouch containing unused patches after each use

Other Ingredients:

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Citrus Medica Limonum (Lemon) Peel Oil, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.

Patient Medication Information

This topical pain relief patch was recently reformulated by pharmacists who specialize in pain management. Natural ingredients have been added to these patches for a better, more refreshing scent. Scientific studies have shown that both ingredients used in this product significantly reduce pain and inflammation.


i A combination of ingredients with analgesics and anesthetic properties are used in a unique way to maximize its pain relieving effects and to aid in addition to other therapies. This offers long lasting relief for a variety of pain conditions. Limencin Patch is manufactured in accordance with FDA regulations by an FDA approved manufacturer.

Mechanism Of Action:

Menthol has some local anesthetic and counterirritant qualities and also acts as a weak kappa opioid receptor agonist making it an analgesic as well. Its ability to chemically trigger the cold-sensitive TRPM8 receptors in the skin is responsible for its cooling sensation when applied to the skin. Lastly, it enhances the efficacy of other topical applications by increasing penetration via vasodilation. Lidocaine is a common local anesthetic that relieves itching, burning, and pain. Topically, it blocks both initiation and conduction of nerve impulses by decreasing ionic flux through the neuronal membrane. Since it penetrates the skin, it creates an anesthetic effect by not just preventing pain signals from propagating to the brain, but by stopping them before they begin.

Benefits:

The use of this topical medication, Limencin Patch, over other oral options for pain relief can benefit patients in many different ways. Conventional therapies using opioids (hydrocodone, hydromorphone, morphine, oxycodone) can cause systemic adverse effects such as constipation, drowsiness, dizziness, lightheadedness, nausea, vomiting, sedation, and/or confusion. NSAIDs (ibuprofen, naproxen) can increase cardiovascular risk, decrease platelet aggregation, and cause gastrointestinal bleeding or ulcers. Other classes of medications such as antidepressants (nortriptyline, duloxetine) or anticonvulsants (gabapentin) also come with its costs and side effects. Limencin Patch acts only locally since it penetrates the skin and not into the bloodstream. In addition, patients can have one or multiple disease states including renal or hepatic dysfunction which can prevent them from taking ibuprofen (Advil) or acetaminophen (Tylenol) respectively. More importantly, this patch gives physicians an option to provide effective pain relief treatment while avoiding the addictive properties of conventional oral medications. It can also be supplemented with other topical pain lotions. In addition, it avoids messy application and reduces risk of getting ingredients in eyes or other mucous membranes.

Product Information And Data:

Pharmacists that have been in the field of pain management for many years used research from all parts of the world to carefully formulate this patch in order to maximize its pain relieving properties.


iii Skin penetrating mixtures have also been added to enhance rapid absorption of the active ingredients through the skin to allow deeper penetration into the muscles, joints, and nerves. Lidocaine patches for therapy of neuropathic and non-neuropathic pain was concluded “to be an effective and safe option for add-on therapy” (Nervenarzt, 2010) in a clinical case series using 87 patients.


iv Another study in 2010 concluded that a single 8 hour application of a combination patch of menthol provided signigicant pain relief associated with mild to moderate strains when compared to a placebo patch.


v The use of these pharmaceutical and natural components provides more pain relief and makes the patch a new way to address pain. These ingredients comply with The Chronic Pain Medical Treatment Guidelines and the ACOEM guidelines for pain management.


vi Page 111 of the Chronic Pain Medical Treatment Guidelines concludes that topical analgesics are “primarily recommended for neuropathic pain when trials of antidepressants and anticonvulsants have failed (Namaka, 2004).” In addition to this, “these agents are applied locally to painful areas with advantages that include lack of systemic side effects, absence of drug interactions, and no need to titrate (Colombo, 2006).” This product is “recognized as safe and effective” because it meets all conditions of the CFR.


vii Limencin Patch complies with The Chronic Pain Medical Treatment Guidelines and the ACOEM guidelines for a variety of pains mentioned above.


viii

Adverse Reactions

Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. Please be aware of any unpleasant side effects as described. If any of these effects persists or worsens, contact your physician or pharmacist immediately. This medication is not absorbed systemically but if any serious side effects (i.e. rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician. This is not a complete list of all side effects that may occur. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch

Warnings And Precautions

• For external use only. Use only as directed or by a health professional. • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucus membranes. •Do not cover with bandage.•Consult your physician: if pregnant or if pain persists and/or worsens•Consult your physician: if pain persists or worsens or if using any other topical pain products.• Store in a dry, cool place

Keep Out Of Reach Of Children

Consult physician for children under 12 years.

Overdosage

In Case of Ingestion or Overdose, get medical help or contact a Poison Control Center (800-222-1222) right away.

References

  • Dunteman E. Targeted peripheral analgesics in Chronic Pain Syndromes. Practical Pain Management 2005; July/August: 14-25
  • Jones M. Chronic neuropathic pain: Pharmacologic interventions in the new millennium. A theory of efficacy. International J Pharmaceutical Compounding. 2004(1):6-15.
  • Baron R, Mahn F. Types of topical treatment for peripheral neuropathic pain: Mechanism of action and indications. Schmerz 2010;24(4):317-25.
  • Kern KU, Kohl M, Kiefer RT. Lidocaine patch for therapy of neuropathic and non-neuropathic pain. A clinical case series of 87 patients. Nervenarzt 2010 Dec;81(12): 1490-7
  • Higashi Y, Kiuchi T, Furuta K. Efficacy and safety profile of a topical methyl salicylate and menthol patch in adult patients with mild to moderate muscle strain: a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Clinical Therapeutics. 2010 Jan;32(1): 34-43.
  • ACOEM. Occupational Medicine Practice Guidelines, 2nd Edition. American College of Occupational and Environmental Medicine, 25 Northwest Point Blvd., Suite 700, Elk Grove Village, Illinois, 60007-1030 (www.acoem.org.). 2004:116.
  • CFR – Code of Federal Regulations. Food and Drug Administration. Chapter 1: Part 346. Revised April 1, 2010.
  • Chronic Pain Medical Treatment Guidelines, Medical Treatment Utilization Schedule (MTUS). Effective July 18, 2009.

* Please review the disclaimer below.