NDC Code(s) : 0374-5110-01
Packager : Lyne Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluocinolone Acetonide Fluocinolone Acetonide Oil OIL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0374-5110
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOCINOLONE ACETONIDE(UNII: 0CD5FD6S2M)
(FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M) 		FLUOCINOLONE ACETONIDE0.11 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL(UNII: ND2M416302)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LIGHT MINERAL OIL(UNII: N6K5787QVP)
OLETH-2(UNII: 7L6R1SQ6M0)
PEANUT OIL(UNII: 5TL50QU0W4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0374-5110-0120 mL in 1 BOTTLE Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203378 07/01/2016

PRINCIPAL DISPLAY PANEL

NDC 0374-5110-01

Fluocinolone
Acetonide Oil
0.01%
(EAR DROPS)

FOR OTIC USE ONLY
NOT FOR OPHTHALMIC USE

Rx Only

Net Contents 20 mL

Carton (Ear Drops)Carton (Ear Drops)