{"contraindications":["CONTRAINDICATIONS Captracin Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation."],"description":["DESCRIPTION Captracin Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Captracin 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. Captracin is a single-use patch stored in a foil pouch. Each Captracin patch is 7.6 cm x 12.7 cm (97 cm²) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner. The empirical formula for capsaicin is C H NO , 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 H O, 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 Captracin Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Captracin patch contains the following inactive ingredients: Non-Toxic Acrylic. chemical structure chemical structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Captracin patch contains 0.0375% capsaicin and 5.00% menthol. Instructions for Use Clean and dry affected area Tear open pouch. Unseal bag 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> <col/> <col/> <tbody> <tr> <td> Adults and children 12 years and over </td> <td> <list listType=\"unordered\" styleCode=\"Disk\"> <item>apply to affected area</item> <item>change patch 1 to 2 times daily</item> </list> </td> </tr> <tr> <td> Children under 12 years</td> <td> <list listType=\"unordered\" styleCode=\"Disk\"> <item>consult physician before use</item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20141208","how_supplied":["HOW SUPPLIED Captracin Patch is supplied in cartons with 5 re-sealable pouches containing 3 patches each. NDC 69036-098-15 15 Patches per carton Storage: Store below 25°C. Avoid direct sunlight. Manufactured for and Distributed by: SALLUS LABORATORIES, LLC Birmingham, AL 35242 205-314-4780 Made in USA"],"id":"ebd00529-834c-4f74-92e9-fd0cf8dbdec1","indications_and_usage":["INDICATIONS AND USAGE Captracin Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness. Captracin Patch is an external analgesic/counterirritant."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC # 69036-098-15 RX Only Captracin Captracin, USP 0.0375% Menthol, NF 5.00% 15 Patches NDC # 69036-098-15 RX Only Captracin Captracin, USP 0.0375% Menthol, NF 5.00% 15 Patches"],"set_id":"7f7b0a37-7129-466c-bb00-0e157bb24ed0","spl_product_data_elements":["Captracin Menthol and Capsaicin CAPSAICIN CAPSAICIN MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ACRYLIC ACID"],"version":"4","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"]}