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. 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.

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.

PURPOSE

MaC Patch purpose is to be used for the temporary relief of minor aches and muscle pains 

INTENDED USE

Use for temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness

KEEP OUT OF REACH OF CHILDREN

MaC Patch should not be stored within reach of children

ACTIVE INGREDIENTS

MaC Patch contains 5.0% menthol and 0.0375% capsaicin

INACTIVE INGREDIENTS

MaC Patch contains the following inactive ingredients:  Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Vera Leaf, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, lodoproynyl Butylcabamate, Propylparaben.

DOSAGE AND ADMINISTRATION

MaC Patch contains 5.00% menthol. and 0.0375% capsaicin and

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.

HOW SUPPLIED

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

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

PACKAGE LABEL

MaC Patch package label