Proctosol-HC
Proctosol-HC 2.5% (Hydrocortisone Cream, USP)
Approved
Approval ID
565284e7-4994-486b-8267-18bd166655ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code10631-407
Application NumberANDA088799
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (14)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
HYDROCORTISONEActive
Quantity: 25 mg in 1 g
Code: WI4X0X7BPJ
Classification: ACTIB
PROPYLENE GLYCOL MONOPALMITOSTEARATEInactive
Code: F76354LMGR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LANOLIN OILInactive
Code: OVV5IIJ58F
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT