Procto-Med HC
Procto-Med HC 2.5% (Hydrocortisone Cream USP, 2.5%) Rx only
Approved
Approval ID
0682580e-aff8-4b67-99ba-a29ab7b433db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2021
Manufacturers
FDA
Leading Pharma, LLC
DUNS: 079575060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCORTISONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69315-312
Application NumberANDA085025
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCORTISONE
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (8)
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT