PROCORT
PROCORT (hydrocortisone acetate and pramoxine hydrochloride) cream
Approved
Approval ID
9e899b72-a16e-4b55-93b5-ab5baec37d50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2023
Manufacturers
FDA
Womens Choice Pharmaceuticals LLC
DUNS: 833067841
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
1.85% hydrocortisone acetate - 1.15% pramoxine hci cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50967-357
Product Classification
G
Generic Name
1.85% hydrocortisone acetate - 1.15% pramoxine hci cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 18, 2023
FDA Product Classification
INGREDIENTS (10)
AMINOMETHYL PROPANEDIOLInactive
Code: CZ7BU4QZJZ
Classification: IACT
BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)Inactive
Code: 389H2R62BD
Classification: IACT
POLOXAMER 124Inactive
Code: 1S66E28KXA
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 18.5 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
PRAMOXINE HYDROCHLORIDEActive
Quantity: 11.5 mg in 1 g
Code: 88AYB867L5
Classification: ACTIB