DESCRIPTION

Atendia patch contains 4% lidocaine and 3% menthol in a localized topical dermal delivery system where lidocaine and menthol are applied to a polyester backing film coated with a drug-containing acrylic adhesive formulation, and covered with a removable paper release liner. The release liner is removed prior to application to the skin. The size of the patch is 3 in. x 5 in.

Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:

Menthol is chemically designated as [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol] and is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:

Each adhesive patch contains 4mg of lidocaine and 3mg of menthol per 100mg.

INDICATIONS AND USAGE

Atendia Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness. Atendia Patch is a topical anesthetic and external analgesic/counterirritant.

CONTRAINDICATIONS

Atendia Patch is contraindicated in patients with a known history of any sensitivity to menthol, local anesthetics of amide type, or to any other component of the product.

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 18.
• Do not use if you are allergic or have hypersensitivity to menthol, lidocaine, or any other component of the product.
• Stop use if allergic reaction occurs and consult 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.
• Stop use if any application site reactions occur.
• KEEP OUT OF THE REACH OF CHILDREN.

DOSAGE AND ADMINISTRATION

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.

HANDLING AND DISPOSAL

Hands should be washed after the handling of Atendia Patch, and eye contact with Atendia Patch should be avoided. Do not store patch outside the sealed protective pouch. Apply immediately after removal from the protective pouch. Fold used patches so that the adhesive sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Atendia should be kept out of the reach of children.

HOW SUPPLIED

Atendia Patch is supplied in 3 re-sealable pouches each containing 5 patches.
NDC 69263-022-15
15 Patches per carton
Rx

Storage:

Storage: Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Avoid direct sunlight.

Distributed by:
Oaklock Bio, LLC
276 Nissan Parkway
Canton, MS 39046

Revised: March 2015

PRINCIPAL DISPLAY PANEL