{"contraindications":["CONTRAINDICATIONS Sinelee Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation."],"description":["DESCRIPTION Sinelee Patch contains capsaicin and menthol in a localized topical dermal delivery system. The capsaicin in Sinelee 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. Sinelee is a single-use patch stored in a foil pouch. Each Sinelee patch is 3 in x 5 in and 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 C 18 H 27 NO 3 , 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 C 10 H 20 O, with a molecular weight of 156.27. The chemical compound menthol [(1 R ,2 S ,5 R )-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 Sinelee Patch contains 0.05% capsaicin (0.05 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Sinelee patch contains the following inactive ingredients: Methacrylic acid, Ethylhexylacrylate, Bentonite, and Sodium Stearate capasaicin chemical structure menthol chemical structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Sinelee patch contains 0.05% 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=\"100%\"> <col width=\"42%\"/> <col width=\"42%\"/> <tbody> <tr styleCode=\"Toprule\"> <td> <paragraph>Directions</paragraph> </td> <td/> </tr> <tr> <td styleCode=\"Rrule Botrule \"> <paragraph>Adults and children 12 years and over</paragraph> </td> <td> <list listType=\"unordered\"> <item>apply to affected area </item> <item>change patch 1 to 2 times daily </item> </list> </td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule Toprule \"> <paragraph>Children under 12 years</paragraph> </td> <td styleCode=\"Lrule Toprule \"> <list listType=\"unordered\"> <item>consult physician before use </item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20150826","how_supplied":["HOW SUPPLIED Sinelee Patch is supplied in 3 re-sealable pouches each containing 5 patches. NDC 69263-021-15 15 Patches per carton Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Avoid direct sunlight. Distributed by: OakLock Bio, LLC. Canton, MS"],"id":"1e3815c2-4555-2f2c-e054-00144ff8d46c","indications_and_usage":["INDICATIONS AND USAGE Sinelee Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness. Sinelee Patch is an external analgesic/counterirritant."],"openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 69263-021-15 Rx only SINELEE ®PATCH (5% Menthol, 0.05% Capsaicin) For Topical Use Only Contains 15 Patches Inactive Components: Methacrylic Acid, Ethylhexylacrylate, Bentonite, Sodium Stearate Full Prescribing and Application Information Enclosed Distributed by: OakLock Bio, Canton, MS Store at 20-25°C (68-77°F) [See USP controlled room temperature] Carton Label"],"set_id":"b3a3796e-e71a-4da3-9441-32c971ef51bf","spl_product_data_elements":["Sinelee Menthol and Capsaicin 2-ETHYLHEXYL ACRYLATE METHACRYLIC ACID BENTONITE SODIUM STEARATE MENTHOL MENTHOL CAPSAICIN CAPSAICIN"],"version":"3","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."]}