PROSKI BENZO
BENZOYL PEROXIDE GEL BP
Approved
Approval ID
2c75b3b9-6321-dede-e063-6394a90a5880
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 18, 2025
Manufacturers
FDA
PHARMAMED USA INC
DUNS: 065607328
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 Code84289-216
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
BENZOYL PEROXIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 18, 2025
FDA Product Classification
INGREDIENTS (7)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ROSE OILInactive
Code: WUB68Y35M7
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZOYL PEROXIDEActive
Quantity: 5 g in 100 g
Code: W9WZN9A0GM
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT