Sinelee label

Sinelee

Sinelee Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

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For external use only.
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Use only as directed.
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Avoid contact with eyes and mucous membranes.
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Do not cover with bandage.
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Do not use on wounds or damaged skin.
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Consult physician for children under 12.
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Do not use if you are allergic to Menthol.
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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.
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KEEP OUT OF REACH OF CHILDREN.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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:

capasaicin chemical 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:

menthol chemical 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

Sinelee Manufacturers

  • Oaklock, Llc
    Sinelee | Oaklock, Llc
    No Recall

    Sinelee | Oaklock, Llc

    Sinelee | Oaklock, Llc

    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
  • Oaklock, Llc
    Sinelee | Oaklock, Llc
    No Recall

    Sinelee | Oaklock, Llc

    Sinelee | Oaklock, Llc

    Atendia Patch contains 4% lidocaine and 3% menthol. Patches may be cut into smaller sizes with scissors prior to removal of the release liner.
    Clothing may be worn over the area of application.

    INSTRUCTIONS FOR USE Clean and dry affected area. Cut open pouch and remove patch Remove protective film and apply on intact skin 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 18 years and over Apply to affected area. Change patch 1 to 3 times daily. Children under 18 years Consult physician before use.