BACITRACIN- bacitracin ointment 
Paddock Laboratories, LLC

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Bacitracin Ophthalmic Ointment USP

STERILE Rx Only

DESCRIPTION:

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

CLINICAL PHARMACOLOGY:

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

INDICATIONS AND USAGE:

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

CONTRAINDICATIONS:

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

PRECAUTIONS:

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.

ADVERSE 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 Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE 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.

HOW SUPPLIED:

NDC 0574-4022-13 3 – 1 g sterile tamper evident tubes with ophthalmic tip.

NDC 0574-4022-35 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].

Manufactured For

Perrigo®

Minneapolis, MN 55427

0S400 RC J1

Rev 08-13 A

R0813

Ini0813

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Carton (Sample Only)

Rx Only

NDC 0574-4022-01

Bacitracin Ophthalmic Ointment USP

FOR USE IN THE EYES ONLY

NET WT 1 g

STERILE

Bacitracin Ophthalmic Ointment 1 g Carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

Rx Only

NDC 0574-4022-11

Bacitracin Ophthalmic Ointment, USP 500 units/g

FOR USE IN THE EYES ONLY

NET WT 1 g

STERILE

Bacitracin Ophthalmic Ointment 1 g Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3 – 1 g Tube Carton

Rx Only

NDC 0574-4022-13

Bacitracin Ophthalmic Ointment USP, 500 units/g

3 – 1 g tubes

Sterile Ophthalmic Ointment

FOR USE IN THE EYES ONLY

Weighing 1 gram each

Bacitracin Ophthalmic Ointment 3-1 g Tubes Carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

Rx Only

NDC 0574-4022-11

Bacitracin Ophthalmic Ointment, USP 500 units/g

FOR USE IN THE EYES ONLY

NET WT 1 g

STERILE

Bacitracin Ophthalmic Ointment 1 g Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton

Rx Only

NDC 0574-4022-35

Bacitracin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 oz)

STERILE

Bacitracin Ophthalmic Ointment 3.5 g Carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Label

Rx Only

NDC 0574-4022-35

Bacitracin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 oz)

STERILE

Bacitracin Ophthalmic Ointment 3.5 g Label
BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0574-4022
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (BACITRACIN) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
MINERAL OIL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0574-4022-011 in 1 CARTON
1NDC:0574-4022-111 g in 1 TUBE
2NDC:0574-4022-133 in 1 CARTON
2NDC:0574-4022-111 g in 1 TUBE
3NDC:0574-4022-351 in 1 CARTON
33.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06121203/10/2014
Labeler - Paddock Laboratories, LLC (967694121)

Revised: 12/2013
Document Id: 6ed2f2bd-9d2f-46af-a44c-95a02ca034de
Set id: 6ed2f2bd-9d2f-46af-a44c-95a02ca034de
Version: 1
Effective Time: 20131226
 
Paddock Laboratories, LLC