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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

ZELSUVMI is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 1 year of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Application site reactions, including allergic contact dermatitis, have occurred in patients treated with ZELSUVMI. Suspect allergic contact dermatitis in the event of pain, pruritus, swelling, or erythema at the application site lasting longer than 24 hours. If allergic contact dermatitis occurs, discontinue ZELSUVMI and initiate appropriate therapy.

ADVERSE REACTIONS

The most commonly reported adverse reactions (incidence ≥1%) are application site reactions, including pain (such as burning or stinging sensations, 18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%). Other adverse reactions include pyrexia (2.2%), vomiting (1.3%), and upper respiratory tract infection (1.2%).

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data with use of ZELSUVMI in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Lactation: There are no data on the presence of berdazimer in human or animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZELSUVMI and potential adverse effects on the breastfed child.

Pediatric: The safety and effectiveness of ZELSUVMI have not been established in pediatric patients younger than 1 year of age.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may request medical information and report adverse events or product complaints to Pelthos Inc. by calling 1-855-330-7546 or sending an email to medinfo@pelthos.com.

Please see the full Prescribing Information and Instructions for Use for ZELSUVMI.

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