DESCRIPTION

AnodyneRx Patch contains menthol, lidocaine and capsaicin in a localized topical dermal delivery system. The capsaicin in AnodyneRx 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.

 AnodyneRx is a single-use patch stored in a foil pouch. Each AnodyneRx patch is 8.5 cm x 12.5 cm and consists of a polyester backing film coated with an ingredient 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:

The empirical formula for lidocaine is C14H22N2O, with a molecular weight of 234.34.  It has the following structure:

Each AnodyneRx Patch contains 5.00% menthol (5 grams of menthol per patch) 2.50% lidocaine (2.5 grams of lidocaine per patch) and 0.05% capsaicin (0.05 grams of capsaicin per patch). The AnodyneRx patch contains the following inactive ingredients: Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Talc, Tartaric Acid, Titanium Dioxide, Water.

INDICATIONS AND USAGE

AnodyneRx Patch is indicated for the temporary relief of minor aches and muscle strains associated with arthritis, simple backache, strains, muscle soreness and stiffness. AnodyneRX Patch is an external counterirritant.

CONTRAINDICATIONS

AnodyneRx Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

• For external use only.
• Avoid contact with eyes and mucous membranes.
• Do not apply to open wounds or damaged skin or use with a heating pad.
• Does not require additional cover bandage.
• Do not use if allergic or sensitive to Menthol or Lidocaine.
• Stop use and ask a doctor if condition worsen, symptoms persist for more than 7 days.
• Stop use and ask a doctor if condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
• Contact physician if rash, blistering, itching or excessive skin irritation occurs.
• If swallowed, consult physician.
• If pregnant or breast feeding, contact a physician prior to use.
• KEEP OUT OF REACH OF CHILDREN.
  

Dosage and Administration Directions

AnodyneRx patch contains 5.00% menthol, 2.5% lidocaine and 0.05% capsaicin.

Directions:

Adults and children 12 years and over                          Apply to affected area

Children under 12 years                                              Consult physician before use

Instructions for use:

• Clean and dry affected area.
• Remove patch from backing and apply to affected area.
• Use only one patch at a time, and a maximum of 3 patches per day.
• Leave patch on affected area for up eight hours.
• Reseal pouch containing unused patches.
• Children under 12 should consult a physician prior to use.
• Wash hands with soap and water after use.
  

Other Ingredients

Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Talc, Tartaric Acid, Titanium Dioxide, Water

Store

Store at 20°-25° C (68°-77° F) (See UP controlled room temperature). Avoid direct sunlight.

AnodyneRx Patch Label

NDC 75840-090-15                              Rx only

AnodyneRx Patch

MEDICATED PATCH

(5% Menthol, 2.5% Lidocaine 0.05% Capsaicin)

For Topical Use Only

15 PATCHES                  Patch Size: 8cm x 12 cm                 Qty: 15 Patches

Distributed By:
GenPak Solutions LLC
4324 Reynolds Drive
Hilliard, Ohio 43026

Lot #:
Expiration Date: