PROCTOZONE-HC
PROCTOZONE–HC® 2.5% (Hydrocortisone Cream, USP 2.5%) FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE
Approved
Approval ID
bfafb095-6dd1-4a38-88a7-16f6e0aa8de5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocortisone 2.5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2396
Application NumberANDA040879
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone 2.5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (13)
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7J
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT