EPSOLAY
These highlights do not include all the information needed to use EPSOLAY safely and effectively. See full prescribing information for EPSOLAY. EPSOLAY (benzoyl peroxide) cream, for topical use Initial U.S. Approval: 1984
Approved
Approval ID
507e2cd7-6bcf-4606-bc62-694d64537701
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2023
Manufacturers
FDA
Galderma Laboratories, L.P.
DUNS: 047350186
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzoyl Peroxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0299-5890
Application NumberNDA214510
Product Classification
M
Marketing Category
C73594
G
Generic Name
Benzoyl Peroxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 20, 2023
FDA Product Classification
INGREDIENTS (16)
Benzoyl PeroxideActive
Quantity: 50 mg in 1 g
Code: W9WZN9A0GM
Classification: ACTIB
Cetrimonium ChlorideInactive
Code: UC9PE95IBP
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Glyceryl Mono And DipalmitostearateInactive
Code: KC98RO82HJ
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Lactic Acid, Unspecified FormInactive
Code: 33X04XA5AT
Classification: IACT
Peg-100 StearateInactive
Code: YD01N1999R
Classification: IACT
PhenoxyethanolInactive
Code: HIE492ZZ3T
Classification: IACT
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw)Inactive
Code: 0L414VCS5Y
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
CyclomethiconeInactive
Code: NMQ347994Z
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT