Pliaglis Dosage

PLIAGLIS™ 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™ 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™ 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™ 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™ 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™ that approximates the amount required to achieve proper coverage. Then spread PLIAGLIS™ 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™ by grasping a free-edge with your fingers and pulling it away from the skin.

If skin irritation or a burning sensation occurs during application, remove PLIAGLIS™.