BACITRACIN
Fera Pharmaceuticals

BACITRACIN OPHTHALMICOINTMENT USPSTERILE

BACITRACIN- bacitracin ointment 
Fera Pharmaceuticals

BACITRACIN
OPHTHALMIC
OINTMENT USP
STERILE

Rx Only

2DESCRIPTION:

Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

3ACTION:

The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

4INDICATIONS:

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

5CONTRAINDICATIONS:

This product should not be used in patients with a history of hypersensitivity to Bacitracin.

6PRECAUTIONS:

Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.

7ADVERSE REACTIONS:

Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604, Monday - Friday 9am - 5pm EST, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8DOSAGE AND ADMINISTRATION:

The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.

9HOW SUPPLIED:

NDC 48102-007-13 3 - 1 g sterile tamper evident tubes with ophthalmic tip.

NDC 48102-007-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.

Store at 20°-25° C (68°-77° F) (See USP Controlled room temperature).

Fera logo

Manufactured for:

Fera Pharmaceuticals, LLC
Locust Valley, NY 11560

PF00735A
R1111

11PRINCIPAL DISPLAY PANEL - 3x1 g tubes, Carton Label

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.

12PRINCIPAL DISPLAY PANEL - 1 g tube, Immediate Container Label

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

13PRINCIPAL DISPLAY PANEL - 3.5 g tube, Carton Label

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

14PRINCIPAL DISPLAY PANEL - 3.5 g tube, Immediate Container Label

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

BACITRACIN 
bacitracin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:48102-007
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 500 [iU]  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
PETROLATUM  
Packaging
# Item Code Package Description
1 NDC:48102-007-35 1 in 1 CARTON
1 3.5 g in 1 TUBE
2 NDC:48102-007-13 3 in 1 CARTON
2 NDC:48102-007-11 1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061212 01/11/2010
Labeler - Fera Pharmaceuticals (831023713)

Revised: 09/2012
 
Fera Pharmaceuticals

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