Eskata
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
Approved
Approval ID
52f4cc49-6553-426f-9778-0bd34e31b942
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 27, 2019
Manufacturers
FDA
Aclaris Therapeutics, Inc.
DUNS: 032365882
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrogen peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71180-001
Application NumberNDA209305
Product Classification
M
Marketing Category
C73594
G
Generic Name
hydrogen peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 27, 2019
FDA Product Classification
INGREDIENTS (3)
HYDROGEN PEROXIDEActive
Quantity: 40 mg in 100 mg
Code: BBX060AN9V
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
hydrogen peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71180-002
Application NumberNDA209305
Product Classification
M
Marketing Category
C73594
G
Generic Name
hydrogen peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 27, 2019
FDA Product Classification
INGREDIENTS (3)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROGEN PEROXIDEActive
Quantity: 40 mg in 100 mg
Code: BBX060AN9V
Classification: ACTIB