Generic Name: capsaicin and menthol
Dosage Form: patch
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Medworx Patch Description
Medworx Patch contains capsaicin and menthol in a localized topical dermal delivery system. The capsaicin in Medworx is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. The menthol is slightly soluble in water.
Medworx Patch is a single-use patch stored in a foil pouch. Each Medworx Patch is 3 inch × 5 inch consists of a polyester backing film coated with a drug containing silicone adhesive formulation, and covered with a removable polyester release liner.
The empirical formula for capsaicin is C18H27NO3, with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:
The empirical formula for menthol is C10H20O, with a molecular weight of 156.27. The chemical compound menthol [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol ] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:
Each Medworx Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Medworx Patch contains the following inactive ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.
Indications and Usage for Medworx Patch
Medworx Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Medworx Patch is an external analgesic/counterirritant.
Medworx Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the product.
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.
Consult physician for children under 12.
Do not use if you are allergic to Menthol.
Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
KEEP OUT OF REACH OF CHILDREN.
There are no adequate and well-controlled studies in pregnant women. Medworx Patch should be used during pregnancy only if clearly needed.
Medworx Patch has not been studied in nursing mothers. Caution should be exercised when administered to a nursing mother.
Safety and effectiveness in pediatric patients have not been established. Consult a physician for use in children under 12 years of age.
To report adverse side effects or to obtain product information, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033.
Medworx Patch Dosage and Administration
Medworx Patch contains 0.0375% capsaicin and 5.00% menthol.
Instructions for Use
Clean and dry affected area
Cut open pouch and remove patch
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
|Adults and children 12 years and over||apply to affected area
change patch 1 to 2 times daily
|Children under 12 years||consult physician before use|
How is Medworx Patch Supplied
Medworx Patch is supplied in 3 re-sealable pouches each containing 5 patches.
|NDC 28595-030-15||15 Patches per carton|
Store below 25°C (77°F).
Avoid direct sunlight.
Allegis Pharmaceuticals, LLC
Canton, MS 39046
Made in China
PRINCIPAL DISPLAY PANEL - 15 Patch Carton
Capsaicin, USP 0.0375%
Menthol, NF 5.00%
For External Use Only
capsaicin and menthol, unspecified form patch
|Labeler - Allegis Pharmaceuticals, LLC (792272861)|