LIMENCIN- lidocaine and menthol patch

Limencin by

Drug Labeling and Warnings

Limencin by is a Otc medication manufactured, distributed, or labeled by Alexso Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients:

Menthol 4%

Purpose

Topical Analgesic

Active ingredients:

Lidocaine 4%

Purpose

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

• i. Dunteman E. Targeted peripheral analgesics in Chronic Pain Syndromes. Practical Pain Management 2005; July/August: 14-25
• ii. Jones M. Chronic neuropathic pain: Pharmacologic interventions in the new millennium. A theory of efficacy. International J Pharmaceutical Compounding. 2004(1):6-15.
• iii. Baron R, Mahn F. Types of topical treatment for peripheral neuropathic pain: Mechanism of action and indications. Schmerz 2010;24(4):317-25.
• iv. 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
• v. 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.
• vi. 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.
• vii. CFR – Code of Federal Regulations. Food and Drug Administration. Chapter 1: Part 346. Revised April 1, 2010.
• viii. Chronic Pain Medical Treatment Guidelines, Medical Treatment Utilization Schedule (MTUS). Effective July 18, 2009.

Principal Display Panel – Carton Label

Limencin Patch

Topical Pain Patch
for long lasting relief

NDC: 50488-1201-1

Qty: 10 Articulated Patches
(5 per Resealable Pouch) x 2

Manufactured for:

Alexso, Inc.
2317 Cotner Avenue
Los Angeles, CA 90064
www.alexso.com
888-495-6078

Store in a dry, cool place

For Comments or Questions, call 888-495-6078

Patent Pending

INGREDIENTS AND APPEARANCE

LIMENCIN 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-1201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-1201-1	2 in 1 CARTON	08/01/2014
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2014

Labeler - Alexso Inc. (963338061)