"83565-001-01" National Drug Code (NDC)

NDC Code	83565-001-01
Package Description	100 mL in 1 BOTTLE (83565-001-01)
Product NDC	83565-001
Product Type Name	HUMAN OTC DRUG
Proprietary Name	Pureskin Seborrheic Dermatitis Eczema Cream
Non-Proprietary Name	Seborrheic Dermatitis Eczema Cream
Dosage Form	CREAM
Usage	TOPICAL
Start Marketing Date	20230707
Marketing Category Name	OTC MONOGRAPH FINAL
Application Number	M005
Manufacturer	Stellans Inc.
Substance Name	KETOCONAZOLE
Strength	.5
Strength Unit	g/100mL
Pharmacy Classes	Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]