NDC Code(s) : 48102-016-11
Packager : Fera Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

PRINCIPAL DISPLAY PANEL



Ilotycin Carton Label


Ilotycin Carton Label


NDC 48102-016-11

STERILE   Rx only


ILOTYCINTM

(ERYTHROMYCIN

OPHTHALMIC

OINTMENT USP)

0.5% (5mg/g)


Erythromycin USP
equivalent to 5 mg
erythromycin per gram.

NET WT 1 gram

WARNING:
Keep out of
reach of children.

See crimp of
tube for Lot No.
and Exp. Date.

Mfd. For:
Fera
Pharmaceuticals,
LLC
Locust Valley,
NY  11560

CF01611
R06/10

INGREDIENTS AND APPEARANCE

ILOTYCIN ERYTHROMYCIN OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48102-016
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN(UNII: 63937KV33D)
(ERYTHROMYCIN - UNII:63937KV33D) 		ERYTHROMYCIN0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:48102-016-111 in 1 CARTON
11 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062447 10/12/2010

PRINCIPAL DISPLAY PANEL


Ilotycin Tube Label


Ilotycin Tube Label


NDC 48102-016-11

STERILE     Rx only

ILOTYCINTM

ERYTHROMYCIN

OPHTHALMIC

OINTMENT, USP

0.5% (5mg/g)

NET WT 1 gram



Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

TF01611   Rev. 06/10