{"adverse_reactions":["ADVERSE REACTIONS To report adverse side effects or to obtain product information, contact Allegis Pharmaceuticals, LLC at 1-866-633-9033."],"contraindications":["CONTRAINDICATIONS Medworx Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the product."],"description":["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. Chemical Structure Chemical Structure"],"dosage_and_administration":["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"],"dosage_and_administration_table":["<table width=\"60%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr> <td valign=\"middle\">Adults and children 12 years and over</td> <td>apply to affected area  change patch 1 to 2 times daily</td> </tr> <tr> <td>Children under 12 years</td> <td>consult physician before use </td> </tr> </tbody> </table>"],"effective_time":"20150625","how_supplied":["HOW 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."],"how_supplied_table":["<table width=\"50%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr> <td>NDC 28595-030-15</td> <td>15 Patches per carton</td> </tr> </tbody> </table>"],"id":"9ddddb0b-5cb1-42be-98d0-55c4a0fec2e5","indications_and_usage":["INDICATIONS AND USAGE 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."],"nursing_mothers":["Nursing Mothers Medworx Patch has not been studied in nursing mothers. Caution should be exercised when administered to a nursing mother."],"openfda":{},"package_label_principal_display_panel":["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 Principal Display Panel - 15 Patch Carton"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established. Consult a physician for use in children under 12 years of age."],"precautions":["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."],"pregnancy":["Pregnancy There are no adequate and well-controlled studies in pregnant women. Medworx Patch should be used during pregnancy only if clearly needed."],"set_id":"6e80bda7-31a7-46c1-b49d-1554fc1ee6e5","spl_product_data_elements":["MedWorx CAPSAICIN and MENTHOL, UNSPECIFIED FORM CAPSAICIN CAPSAICIN MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF DIAZOLIDINYL UREA EDETATE DISODIUM GLYCERIN IODOPROPYNYL BUTYLCARBAMATE METHYLPARABEN POLYSORBATE 80 PROPYLPARABEN SODIUM POLYACRYLATE (2500000 MW) WATER"],"spl_unclassified_section":["Rx Only","Manufactured for: Allegis Pharmaceuticals, LLC Canton, MS 39046 Made in China Rx Only Rev 2/2015"],"storage_and_handling":["Storage Store below 25°C (77°F). Avoid direct sunlight."],"version":"2","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. 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."]}