shunned Sinelee Patch Generic Name: menthol and capsaicin Dosage Form: patch Overview Side Effects Dosage Professional Interactions More User Reviews Support Group Q & A 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. 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 8.5 cm x 12.5 cm 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 [(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 Sinelee Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Sinelee Patch contains the following inactive ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodiumm Salt, Glycerin, Iodoproynyl Butylcabamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water. Slideshow Fighting the Fight: Fibromyalgia Explained Indications and Usage for Sinelee Patch 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. Contraindications Sinelee Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation. 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. Sinelee Patch Dosage and Administration Sinelee 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 Sinelee Patch Supplied Sinelee Patch is supplied in 3 re-sealable pouches each containing 5 patches. NDC 69263-020-15 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 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 69263-020-15 Rx only SINELEE PATCH (5% Menthol, 0.0375% Capsaicin) For Topical Use Only Contains 15 Patches Inactive Components: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodiumm Salt, Glycerin, lodoproynyl Butylcabamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water. 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] Lot: Ex: SINELEE menthol and capsaicin patch Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69263-020 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 5 g in 100 g CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0375 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 Packaging # Item Code Package Description 1 NDC:69263-020-15 3 POUCH in 1 CARTON 1 5 PATCH in 1 POUCH 1 100 g in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/12/2014 08/31/2015 Labeler - OakLock, LLC (079559179) Registrant - OakLock, LLC (079559179) Revised: 08/2015 OakLock, LLC Next Interactions Print this page Add to My Med List More about Sinelee Patch (capsaicin / menthol topical) Side Effects Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: topical rubefacient Consumer resources Sinelee Professional resources Other brands: MaC Patch , Aleveer Patch , Ameripatch , Bioaches patch , ... +9 more Related treatment guides Muscle Pain FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Topical rubefacient Related Drugs topical rubefacient Biofreeze , Medrox , menthol topical Muscle Pain acetaminophen , Tylenol , naproxen , ibuprofen , diclofenac , Voltaren , Aleve , Advil , Naprosyn , Motrin , Paracetamol , Anaprox , Mapap , Cataflam , Tylenol Arthritis Pain , Zipsor , Motrin IB , Naprelan , Proprinal , More... 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