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Fluocinolone Acetonide

These highlights do not include all the information needed to use Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) safely and effectively. See full prescribing information for Fluocinolone Acetonide Topical Oil, 0.01%. Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) For topical use only Initial U.S. Approval: 1988 NDC 64980-331-04 For Topical Use Only - Not for Oral, Ophthalmic, or Intravaginal Use

Approved
Approval ID

f45b0ef2-1702-4d21-8ac8-774769304595

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2022

Manufacturers
FDA

Rising Pharmaceuticals, Inc.

DUNS: 041241766

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 Code64980-331
Application NumberANDA203377
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 23, 2017
FDA Product Classification

INGREDIENTS (6)

LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
OLETH-2Inactive
Code: 7L6R1SQ6M0
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
FLUOCINOLONE ACETONIDEActive
Quantity: 0.11 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB

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Fluocinolone Acetonide - FDA Drug Approval Details