Pliaglis (lidocaine and tetracaine) is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.

Pliaglis (lidocaine and tetracaine) should only be applied to intact skin.

For use in adults only.

• For superficial dermatological procedures such as dermal filler injection or facial laser ablation, apply Pliaglis (lidocaine and tetracaine) to intact skin for 20-30 minutes prior to the procedure. See Table 3 below for instructions on the amount to apply.
• For superficial dermatological procedures such as laser-assisted tattoo removal, apply Pliaglis (lidocaine and tetracaine) to intact skin for 60 minutes prior to the procedure. See Table 3 below for instructions on the amount to apply.

In order to minimize the risk of systemic toxicity, do not exceed the recommended amount of drug to apply or the duration of the application (see OVERDOSAGE section).

The dose of Pliaglis (lidocaine and tetracaine) that provides effective local dermal analgesia depends on the duration of the application. Although not specifically studied, a shorter duration of application may result in a less complete dermal analgesia or a shorter duration of adequate dermal analgesia.

Determine the amount of drug to apply

The amount (length) of Pliaglis (lidocaine and tetracaine) that should be dispensed is determined by the size of the area to be treated (see Table 3). Using the ruler supplied on the carton and in the DOSAGE AND ADMINISTRATION section, squeeze out and measure the amount of Pliaglis (lidocaine and tetracaine) that approximates the amount required to achieve proper coverage. Then spread Pliaglis (lidocaine and tetracaine) evenly and thinly (approximately 1 mm or the thickness of a dime) across the treatment area using a flat-surfaced tool such as a metal spatula or tongue depressor. After waiting the required application time, remove the Pliaglis (lidocaine and tetracaine) by grasping a free-edge with your fingers and pulling it away from the skin.

Table 3. Dosage and administration information

If skin irritation or a burning sensation occurs during application, remove Pliaglis (lidocaine and tetracaine) .

Handling and Disposal

Upon removal from the treatment site, discard the used Pliaglis (lidocaine and tetracaine) in a location that is out of the reach of children and pets. Hands should be washed after handling Pliaglis (lidocaine and tetracaine) , and eye contact with Pliaglis (lidocaine and tetracaine) should be avoided. Access to Pliaglis (lidocaine and tetracaine) by children or pets should be prevented during usage and storage of the product.

Used Pliaglis (lidocaine and tetracaine) tubes should be disposed of immediately. Discard used Pliaglis (lidocaine and tetracaine) in a location that prevents accidental ingestion by children or pets.

Pliaglis (lidocaine and tetracaine) Cream 7%/7% is available as the following:

NDC yyyy-yyyy-yy 30 gram tube

Store in a refrigerator, temperature 2-8°C (36-46°F). Do not freeze.

Manufactured for: ZARS, Inc. Salt Lake City, UT 84119. Manufactured by: Janssen Ortho LLC Manati, Puerto Rico 00674. Rev. 1/07. FDA revision date: 6/28/2007

Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.