WARNINGS

• For external use only. Use only as directed. Avoid contact with eyes and mucous membranes
• Do not cover with bandage
• Do not use on wounds or damaged skin.
• Keep out of reach of children under 12. Consult physician for children under 12.
• Do not use if you are allergic to Menthol or Capsaicin
• Stop use and consult a physician if condition worsens, excessive redness, irritation, burning, rash, itching or discomfort of the skin develops, pain persists for more than 7 days or clears up and occur again within a few days

Accidental Exposure in Children
The potential exists for a small child or a pet to suffer serious adverse effect from chewing or ingesting a new or used MaC Patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of MaC Patch out of the reach of children, pets and others.

Excessive Dosing
Excessive dosing by applying MaC Patch to larger areas for longer than the recommended wearing time could result in increased absorption and higher blood concentrations. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increasing the blood concentration.

PRECAUTIONS General

• Allergic Reactions: Patients allergic to Menthol or Capsaicin or any other ingredient in Mac Patch should not use MaC Patch.
• Non-intact Skin:  Application to broken or inflamed skin, although not tested, may result in higher blood concentrations from increased absorption. MaC Patch is only recommended for use on intact skin.
• Eye Exposure:  The contact of MaC Patch with eyes, although not studied, should be avioded based on the findings of sever eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline.
• Pregnancy/Nursing Mothers:  MaC Patch has not been studied in nursing mothers. Caution should be exercised when MaC Patch is administered to a nursing mother.
• Pediatric Use:Safety and effectiveness in pediatric patients and children under the age of 12 have not been established.

DESCRIPTION

Mac Patch (Menthol 5%/Capsaicin 0.0375%) is comprised of an adhesive material containing Menthol and Capsaicin which is applied to a woven polyester backing and covered with a PET film release line. The release liner is removed prior to application to the skin. The size of the patch is 12.5 cm x 8.5cm. Menthol is checmically designated as 2-Isopropyl-5- methylcyclohexanol. It is colourless, hexagonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odour. If has a melting point between 31°C to 36° C. Capsaicin is chemically designated as (6E)-N-(4-Hydroxy-3- methoxybenzyl)-8-methyl-6-nonenamide. It is a crystalline white powder. It has a melting point of 65° C.

Each adhesive patch contains 850 mg of Menthol and 6.375 mg of Capsaicin. It also contains the following inactive ingredients: Water, Glcerin, Sodium Polyacrylate (250000MV), Polysorbate 80, Aloe Vera Leaf, Edetate Disodium, Diazolidinyl Urea, Methylparaben, Iodopropynyl, Butylcarbamate and Propylparaben.

CLINICAL PHARMACOLOGY: Pharmacodynamics

Menthol works by targeting the opiod receptior 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.  Capsaicin is a naturally occurring compound. Iit is found in chili peppers and is what gives is "heat".  Capsaicin has been found to be effective in reducing inflammation and pain. When Capsaicin enters the body it binds with the protein TRPV1 which is located on pain and heat neurons. When the TRPV1 proton is activated (between 37° - 45° C) it opens the calcium ion channel and give the sensation of pain and heat. When Capsaicin binds to the TRPV1 proton it forces the ion channel to open below its normal activation temperature which is why it gives the distinct heating sensation. It is thought that prolonged activation of these neurons by Capsaicin depletes substance P, a neurotransmitter for pain and heat. the end result appears that the nerves are overwhelmed by the influx and unable to report pain for an extended period of time.

INTENDED USE

MaC Patch is intended to be used for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscles soreness and stiffness.

CONTRAINDICATIONS

MaC Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

DOSAGE AND ADMINISTRATION

MaC Patch contains 0.05% capsaicin and 5.00% menthol.

Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily
Children under 12 years, consult a physician before use
How to apply:

• Clean and dry affected area
• Cut open pouch and remove patch
• If desired, cut pad to size
• Remove protective film and apply 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

Apply MaC Patch to intact skin to cover the most painful area. Apply up to four patches in a 24 hour period. Each patchshould not be applied for more than 8 hours in a given 24-hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination.

If irritation or a burning sensation occurs during application, remove the patch and do not reapply until the irritation subsides.

Analgesic/counterirritant

External analgesic

HOW SUPPLIED

MaC Patch is supplied 15 patches per carton.  Each carton contains 3 re-sealable pouches each containing 5 patches.  NDC: 69499-0001-15 

Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

PACKAGE LABEL

MaC Patch package label