Renovo

RENOVO — menthol and capsaicin patch
TMIG, Inc.

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

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 C18 H27 NO3 , 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:

Figure 1
(click image for full-size original)

The empirical formula for menthol is C10 H20 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:

Menthol chair conformation

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.

INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

Renovo 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.

DOSAGE AND ADMINISTRATION

Renovo 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 SUPPLIED

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0fb9595b-figure-03
(click image for full-size original)
RENOVO
menthol and capsaicin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69176-025
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 Multilevel Packaging
1 NDC:69176-025-15 15 PATCH (PATCH) in 1 CARTON contains a PATCH
1 100 g in 1 PATCH This package is contained within the CARTON (69176-025-15)
2 NDC:69176-025-03 3 PATCH (PATCH) in 1 CARTON contains a PATCH
2 100 g in 1 PATCH This package is contained within the CARTON (69176-025-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/25/2014
Labeler — TMIG, Inc. (036572986)
Registrant — TMIG, Inc. (036572986)

Revised: 01/2015 TMIG, Inc.

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