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FDA Approval

PROCORT

CompanyWomens Choice Pharmaceuticals LLC (DUNS: 833067841)

Effective Date

January 18, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone acetate(18.5 mg in 1 g)

Hydrocortisone Acetate/Pramoxine Hydrochloride(11.5 mg in 1 g)

Registrants (1)

Womens Choice Pharmaceuticals LLC

DUNS Number

833067841

Manufacturing Establishments (1)

Multipack Solutions

Labeler

Womens Choice Pharmaceuticals LLC

Registrant

Womens Choice Pharmaceuticals LLC

DUNS Number

557434805

Products (1)

PROCORT

NDC Product Code

50967-357

Route of Administration

TOPICAL

Effective Date

January 18, 2023

Ingredients

AMINOMETHYL PROPANEDIOLInactive

Code: CZ7BU4QZJZClass: IACT

BUTYL ESTER OF METHYL VINYL ETHER-MALEIC ANHYDRIDE COPOLYMER (125 KD)Inactive

Code: 389H2R62BDClass: IACT

POLOXAMER 124Inactive

Code: 1S66E28KXAClass: IACT

PHENOXYETHANOLInactive

Code: HIE492ZZ3TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

POLYSORBATE 60Inactive

Code: CAL22UVI4MClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Hydrocortisone acetateActive

Code: 3X7931PO74Class: ACTIBQuantity: 18.5 mg in 1 g

ALPHA-TOCOPHEROLInactive

Code: H4N855PNZ1Class: IACT

Hydrocortisone Acetate/Pramoxine HydrochlorideActive

Code: 88AYB867L5Class: ACTIBQuantity: 11.5 mg in 1 g

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