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Questions & Answers
Side Effects & Adverse Reactions
- 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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
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 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 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