OTOVEL
These highlights do not include all the information needed to use OTOVEL safely and effectively. See full prescribing information for OTOVEL. OTOVEL (ciprofloxacin and fluocinolone acetonide) otic solution Initial U.S. Approval: 2016
Approved
Approval ID
dc17b816-b97f-4c44-9f05-b41f76ab3a52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2022
Manufacturers
FDA
WraSer LLC
DUNS: 121828334
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciprofloxacin and fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66992-128
Application NumberNDA208251
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciprofloxacin and fluocinolone acetonide
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateOctober 5, 2021
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CIPROFLOXACINActive
Quantity: 0.75 mg in 0.25 mL
Code: 5E8K9I0O4U
Classification: ACTIB
FLUOCINOLONE ACETONIDEActive
Quantity: 0.0625 mg in 0.25 mL
Code: 0CD5FD6S2M
Classification: ACTIB