NDC Code(s) : 0374-5090-01
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:0374-5090
Route of Administration TOPICAL 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:0374-5090-01118.28 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 ANDA090982 07/01/2016

PRINCIPAL DISPLAY PANEL

NDC 0374-5090-01

Fluocinolone
Acetonide
Topical Oil,
0.01%
(SCALP OIL)

FOR TOPICAL USE ONLY
NOT FOR ORAL,
OPHTHALMIC,
or INTRAVAGINAL USE

SHAKE WELL BEFORE USE

Rx Only

Net Contents 118.28 mL
(4 fl. oz.)

Carton (Ear Drops)Carton (Ear Drops)