Important Safety Information:
Indication: PLIAGLIS® (lidocaine and tetracaine) Cream 7%/7% 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. Contraindications: PLIAGLIS® Cream is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type and is also contraindicated in patients with sensitivity to para‐aminobenzoic acid (PABA) or any component of the product. Adverse Events: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%). The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%. Warnings/Precautions: Methemoglobinemia has been associated with use of local anesthetics such as tetracaine. PLIAGLIS® Cream should be used with caution in patients with severe hepatic disease. When using PLIAGLIS® Cream in conjunction with other local anesthetic agents, the total dose of anesthetic should be considered due to the potential for additive systemic toxic effects. Contact with the eyes should be avoided.