RENOVO- menthol and capsaicin patch
Zhuhai Guojia New Macromolecule Materials Co. Ltd.
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.
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Renovo Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Renovo 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.
Renovo is a single-use patch stored in a foil pouch. Each Renovo patch is 8.3 cm x 12.5 cm (104 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 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 Relovo Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). The Renovo 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.
Renovo Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Renovo Patch is an external analgesic/counterirritant.
Renovo Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.
Renovo patch contains 0.0375% capsaicin and 5.00% menthol.
Instructions for Use
Directions
Adults and children 12 years and over |
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Children under 12 years |
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Renovo Patch is supplied in cartons with either 1 re-sealable pouch containing 3 patches or 3 re-sealable pouches each containing 5 patches.
NDC 69176-025-03 3 Patches per carton
NDC 69176-025-15 15 Patches per carton
Storage: Store below 25°C. Avoid direct sunlight.
Distributed by:
TMIG, Inc., Marietta, GA 30062
770-579-8883
Manufactured by:
Pocono Coated Products, LLC
Greensboro, N.C. USA 27407
RENOVO
menthol and capsaicin patch |
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Labeler - Zhuhai Guojia New Macromolecule Materials Co. Ltd. (679871251) |
Registrant - Zhuhai Guojia New Macromolecule Materials Co. Ltd. (679871251) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Zhuhai Guojia New Macromolecule Materials Co. Ltd. | 679871251 | manufacture(69577-025) |