Finished product reference
Lidocaine / Tetracaine
Cream · Topical · 7 %/7 % · 30 g
- List code
- 52924
- Pharmacologic class
- Amide Local Anesthetic · Antiarrhythmic · Ester Local Anesthetic
What it is and how it works
Mechanism of Action Lidocaine is an amide-type local anesthetic agent and tetracaine is an ester-type local anesthetic agent. Both lidocaine and tetracaine block sodium ion channels required for the initiation and conduction of neuronal impulses which, in certain instances, results in local anesthesia. When applied to intact skin, PLIAGLIS provides local dermal analgesia by the release of lidocaine and tetracaine from the peel into the skin.
Indications
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 is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, 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.
Dosage and administration (summary)
Apply only to intact skin. Do not exceed the recommended dose of drug or duration of application. Recommended duration of application : For dermal filler injection ablative laser facial resurfacing, or pulsed-dye laser therapy 20-30 minutes prior to procedure For superficial dermatological procedures such as laserassisted tattoo removal 60 minutes prior to procedure See Full Prescribing Information for amount to apply based upon treatment site surface area. Important Dosage and Administration Instructions For use in adults only. PLIAGLIS should only be applied to intact skin. PLIAGLIS should not be applied to a procedure site after the procedure has been performed.
Contraindications
is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, local anesthetics of the amide or ester type, or to any other component of the product [ see Warnings and Precautions ]. PLIAGLIS is contraindicated in patients with para-aminobenzoic acid (PABA) hypersensitivity. Known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type. Para-aminobenzoic acid (PABA) hypersensitivity.
Warnings and precautions
Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. Overexposure : To avoid overexposure that could lead to adverse effects, do not use for longer duration or over larger surface areas than recommended. consider total amount of local anesthetics absorbed from all formulations. do not apply to mucous membranes or broken or inflamed skin. use with caution in patients who may be more sensitive to systemic effects of PLIAGLIS, including acutely ill or debilitated or those with severe hepatic disease or pseudocholinesterase deficiency.
Pregnancy
Pregnancy Risk Summary There are no available data on PLIAGLIS use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Storage and supply
Refrigerate at 2 to 8°C (36 to 46°F). Do not freeze. PLIAGLIS can be stored at room temperature for up to 3 months. Discard PLIAGLIS after storing at room temperature for 3 months.
Source: Lidocaine And Tetracaine (Pliaglis) — US FDA prescribing information, 2026-03-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.