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Medworx Patch

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

Rx Only

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.

Contraindications

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

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.

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.

Precautions

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Medworx Patch should be used during pregnancy only if clearly needed.

Nursing Mothers

Medworx Patch has not been studied in nursing mothers. Caution should be exercised when administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Consult a physician for use in children under 12 years of age.

Adverse Reactions

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

Directions

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

Storage

Store below 25°C (77°F).

Avoid direct sunlight.

Manufactured for:
Allegis Pharmaceuticals, LLC
Canton, MS 39046

Made in China

Rx Only

Rev 2/2015

PRINCIPAL DISPLAY PANEL - 15 Patch Carton

NDC 28595-030-15
RxOnly

MEDWORX

Patch

Capsaicin, USP 0.0375%
Menthol, NF 5.00%

15 patches
For External Use Only

MEDWORX  
capsaicin and menthol, unspecified form patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:28595-030
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375 g  in 100 g
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF  
DIAZOLIDINYL UREA  
EDETATE DISODIUM  
GLYCERIN  
IODOPROPYNYL BUTYLCARBAMATE  
METHYLPARABEN  
POLYSORBATE 80  
PROPYLPARABEN  
SODIUM POLYACRYLATE (2500000 MW)  
WATER  
Product Characteristics
Color      Score     
Shape RECTANGLE Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:28595-030-15 3 POUCH in 1 CARTON
1 5 PATCH in 1 POUCH
1 9 g in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/17/2015
Labeler - Allegis Pharmaceuticals, LLC (792272861)
Revised: 04/2015
 
Allegis Pharmaceuticals, LLC

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