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Sinelee Patch
  • Professionals
  • FDA PI

Sinelee Patch

Generic name:menthol and capsaicin
Dosage form: patch
Drug class:Topical rubefacient

Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.

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 18H 27NO 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 10H 20O, 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.

Indications and Usage for Sinelee Patch

Sinelee Patch is indicated for the te...