Fluocinolone Acetonide
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
Approved
Approval ID
372a6a06-c9de-48d5-ad02-c4004038f85e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2264
Application NumberANDA088167
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinolone acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 8, 2010
FDA Product Classification
INGREDIENTS (3)
FLUOCINOLONE ACETONIDEActive
Quantity: 0.1 mg in 1 mL
Code: 0CD5FD6S2M
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 11/10/2009
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
Rx only