Hydrocortisone 1%
Hydrocortisone Cream 1% ANTIPRURITIC (Anti-Itch) MAXIMUM STRENGTH
Approved
Approval ID
9987165c-1a0f-dd57-e053-2a95a90ae735
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 8, 2025
Manufacturers
FDA
Trifecta Pharmaceuticals Usa Llc
DUNS: 079424163
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 Code69396-050
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hydrocortisone
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 8, 2025
FDA Product Classification
INGREDIENTS (12)
GLYCERYL MONO AND DIPALMITOSTEARATEInactive
Code: KC98RO82HJ
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCORTISONEActive
Quantity: 1 g in 100 g
Code: WI4X0X7BPJ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT