FDA label 08605c07-e9d0-49b9-9692-0282867e8c05

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
59bd46fa-9460-416d-b4ef-6beeddda96cf
SPL ID
08605c07-e9d0-49b9-9692-0282867e8c05
Version
8
Effective date
2018-01-02
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:50:13

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.