Anodynerx

Anodynerx

Anodynerx Recall

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Questions & Answers

Side Effects & Adverse Reactions

  • 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.

Legal Issues

There is currently no legal information available for this drug.

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

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.

History

There is currently no drug history available for this drug.

Other Information



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:

GenPak Anodyne Label


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:

GenPak Anodyne1 Label

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

GenPak Anodyne2 Label

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.


Anodynerx Manufacturers


  • Genpak Solutions Llc
    Anodynerx (Menthol, Unspecified Form, Lidocaine, Capsaicin) Patch [Genpak Solutions Llc]

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