Mac Patch Recall
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Questions & Answers
Side Effects & Adverse Reactions
- 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.
- 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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Use for temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness
There is currently no drug history available for this drug.
There are no additional details available for this product.