Fluocinolone Acetonide
Fluocinolone Acetonide 0.01% Topical oil(Scalp Oil)
Approved
Approval ID
8d55d846-c833-4040-b02d-ac7783311dd6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2024
Manufacturers
FDA
Seton Pharmaceuticals
DUNS: 828898002
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13925-507
Application NumberNDA019452
Product Classification
M
Marketing Category
C73605
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 10, 2018
FDA Product Classification
INGREDIENTS (6)
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
fluocinolone acetonideActive
Quantity: 0.11 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
OLETH-2Inactive
Code: 7L6R1SQ6M0
Classification: IACT