ACTIVE INGREDIENTS

Menthol 5%
Lidocaine 4%

DESCRIPTION

MaL Patch is a prescription topical patch containing 15 articulated patches (5 per resealable pouch x 3 pouches). Lidocaine is present in a 4% concentration and menthol is present in a 5% concentration.  

PURPOSE

• Topical Analgesic
• Topical Anesthetic

KEEP OUT OF REACH OF CHILDREN

MaL Patch has not been studied in children. Children under 12 years, consult a physician before use.

CLINICAL PHARMACOLOGY

Menthol has local anesthetic and counterirritant qualities, and it also acts as a weak kappa (κ) opioid receptor agonist. Menthol acts to chemically trigger the cold-sensitive TRPM-8 receptors in the skin - responsible for the well-known cooling sensation it stimulates when applied directly to the skin.  Menthol's analgesic properties are not fully understood, however they are mediated through a selective activation of κ-opioid receptors. Menthol also blocks voltage-sensitive sodium channels, reducing neural activity that may stimulate muscle tissue.

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.

INDICATIONS AND USAGE

MaL Patch is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact.

CONTRAINDICATIONS

Known hypersensitivity to menthol, lidocaine, or any of the topical amide-like anesthetic preparations.

WARNINGS

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.

PRECAUTIONS:
Because of the possibility of sedation, patients should be cautioned regarding the operation of serious machinery or automobiles, and activities made hazardous by decreased alertness.

DRUG INTERACTIONS:
No Drug interactions have been assessed with MaL Patch

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Nonclinical toxicity studies to determine the potential of this topical preparation to cause
carcinogenicity or mutagenicity have not been performed. The effect of the product on fertility has not
been evaluated in animals.

PREGNANCY:
The safety of MaL Patch has not been established during pregnancy. There are no well-controlled
studies in pregnant women.

PEDIATRIC / GERIATRIC USE:
Safety and effectiveness in pediatric and geriatric patients have not been established.

NURSING MOTHERS:
The effect of MaL Patch on nursing infants has not been evaluated.

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 MaL Patch are similar in nature to those observed in other amide anestheticcontaining
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 MaL 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.

INACTIVE INGREDIENTS

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

STORAGE

Store at room temperature at 68°F to 77°F (20°C to 25° C). Excursion permitted to 59º-86º F (15º - 30ºC). [See USP Controlled Room Temperature]. Keep away from heat or sunlight. Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.

HOW SUPPLIED

MaL Patch is supplied in the following dosage form: 30 Articulated Patches [ (5 per Re-sealable Pouch) x 3 ]

ADMINISTRATION

Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily. MaL Patch should be worn for 8hours at a time and no more than 12 hours within a 24-hour period. Children under 12 years, consult a physician before use.

Instructions for Use:

• Clean and dry affected area
• Open pouch and remove one patch
• If desired, cut pad to size
• Remove protective film and apply sticky side directly to area of pain
• Apply to affected area not more than 3 times daily
• Wash hands with soap after applying patch
• Reseal pouch containing unused patches. Do not store patch outside the sealed envelope.
• Fold used patches so that the adhesive side sticks to itself and safely discard used patches where children and pets cannot get to them.

MaL Patch package label