Journal of Clinical and Aesthetic Dermatology

APR 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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Page 22 of 61

© 2018 Aclaris Therapeutics, Inc. All rights reserved. PP-ESK-US-0235 03/18 ESKATA is a trademark of Aclaris Therapeutics, Inc. TOPICAL For external, topical use only IN-OFFICE APPLICATION By a healthcare provider AESTHETIC Self-pay billing model Indications and Usage ESKATA ™ (hydrogen peroxide) topical solution, 40% (w/w) is indicated for the treatment of seborrheic keratoses that are raised. IMPORTANT SAFETY INFORMATION ESKATA is to be administered by a healthcare provider. For topical use only. Not for ophthalmic use. Not for open or infected seborrheic keratoses. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Do not apply to the eyes or mucous membranes. Avoid treating seborrheic keratoses within the orbital rim. Direct contact with the eye can cause corneal injury (erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain or permanent eye injury, including blindness. If accidental exposure occurs, flush with water for 15 to 30 minutes, initiate monitoring and further evaluation as appropriate. Skin reactions occurred in the treatment area a er application of ESKATA. Severe local skin reactions included erosion, ulceration, vesiculation and scarring. Do not retreat until the skin has recovered from any reaction caused by the previous treatment. MOST COMMON ADVERSE REACTIONS The most common adverse reactions include erythema (99%), stinging (97%), edema (91%), scaling (90%), crusting (81%), and pruritus (58%). You are encouraged to report negative side eff ects of prescription drugs to the FDA. Contact Aclaris Therapeutics, Inc. at 1-833-ACLARIS or 1-833-225-2747 or FDA at 1-800-FDA-1088 or Please see brief summary of full Prescribing Information. NOW APPROVED For the treatment of raised seborrheic keratoses Get your off ice ready for ESKATA by visiting .

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