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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.