NDC Code(s) : 48102-007-35, 48102-007-11, 48102-007-13
Packager : Fera Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BACITRACINBACITRACIN OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48102-007
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN(UNII: 58H6RWO52I)
(BACITRACIN - UNII:58H6RWO52I) 		BACITRACIN500 [iU] 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:48102-007-351 in 1 CARTON
13.5 g in 1 TUBE
2NDC:48102-007-133 in 1 CARTON
2NDC:48102-007-111 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 01/11/2010

PRINCIPAL DISPLAY PANEL

Bacitracin Ophthalmic Ointment USP, 500 units/g - 3 x 1 g tubes carton label

NDC 48102-007-13

Rx only

BACITRACIN OPHTHALMIC
OINTMENT USP, 500 units/g
STERILE

3 x 1 g tubes

Sterile Ophthalmic Ointment

Weighing 1 gram each

USUAL DOSAGE: Apply 1 to 3 times daily.
See package insert for full prescribing information.

EACH GRAM CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.

Keep tightly closed.

Store at 20°-25° C (68°-77° F) (See USP

Controlled room temperature).

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Bacitracin Ophthalmic Ointment, USP 500 units/g - 1 g tube label

NDC 48102-007-11

STERILE

Rx only

BACITRACIN

OPHTHALMIC
OINTMENT USP

500 units/g

NET WT 1 gm

PRINCIPAL DISPLAY PANEL

Bacitracin Carton Label

NDC 48102-007-35

Rx only

BACITRACIN OPHTHALMIC
OINTMENT USP
STERILE

CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.

NET WT 3.5 g (1/8 Oz)

USUAL DOSAGE: 3 applications daily.
See insert for complete information.

KEEP TIGHTLY CLOSED
STORE AT ROOM TEMPERATURE
KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

Bacitracin Container Label

NDC 48102-007-35

BACITRACIN
OPHTHALMIC
OINTMENT USP
STERILE

Rx only

USUAL DOSAGE: 3 applications daily.
See insert for complete information.

WARNING: Keep out of reach of children.

See crimp for Lot No. and Exp. Date

CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil.

NET WT 3.5 g (1/8 Oz)

KEEP TIGHTLY CLOSED
STORE AT ROOM TEMPERATURE