For: Seborrheic Keratoses
Eskata (hydrogen peroxide) 40% (w/w) topical solution is a high-concentration hydrogen peroxide formulation for the treatment of raised seborrheic keratoses. ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is a clear, colorless solution and is supplied in a unit dose package. The available carton packages are presented below:
Dosage Strength Fill Volume Deliverable Volume Number of unit dose packages per carton NDC#
40% (w/w) 1.5 mL 0.7 mL 1 71180-001-01
3 71180-001-03
12 71180-001-12
2.2 mL 1.3 mL 1 71180-002-01
3 71180-002-03
12 71180-002-12
Store ESKATA at controlled room temperature of 20�C to 25�C (68�F to 77�F), excursions permitted between 15�C and 30�C (59� F and 86� F). These highlights do not include all the information needed to use ESKATA� safely and effectively. See full prescribing information for ESKATA�.
ESKATA� (hydrogen peroxide) topical solution
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
ESKATA is indicated for the treatment of seborrheic keratoses that are raised. (1)
DOSAGE AND ADMINISTRATION
To be administered by a healthcare provider. (2.1)
For topical use only. Not for ophthalmic use. (2.1)
Do not apply ESKATA topical solution to open or infected seborrheic keratoses. (2.1)
Apply 4 times, approximately 1 minute apart, to the targeted lesion(s) during a single in-office treatment session. (2.1)
DOSAGE FORMS AND STRENGTHS
Topical solution: 40% (w/w) hydrogen peroxide (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Eye Disorders: Avoid eye exposure. Eye disorders including corneal injury (erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain, or permanent eye injury, including blindness can occur after exposure. If accidental exposure occurs, flush eyes with water for 15 to 30 minutes and initiate monitoring, and further evaluation as appropriate. (5.1)
Local Skin Reactions: severe reactions, including ulcerations and scarring, may occur. Do not retreat with ESKATA until the skin has recovered from any reaction caused by the previous treatment (5.2)
ADVERSE REACTIONS
Common adverse reactions include erythema (99%), stinging (97%), edema (91%), scaling (90%), crusting (81%), and pruritus (58%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Aclaris Therapeutics, Inc at 1-833-225-2747 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2019
