Bacitracin Zinc and Polymyxin B Sulfate

BACITRACIN ZINC AND POLYMYXIN B SULFATE — bacitracin zinc and polymyxin b sulfate ointment
Physicians Total Care, Inc.

Rx only

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a sterile antimicrobial ointment for ophthalmic use.

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is:

Polymyxin B Sulfate is the sulfate salt of polymyxin B₁ and B₂ which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.

CLINICAL PHARMACOLOGY

Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

Bacitracin Zinc and Polymyxin B Sulfate Indications and Usage

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

CONTRAINDICATIONS

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

DOSAGE AND ADMINISTRATION

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

HOW SUPPLIED

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.

NDC 54868-1199-0

STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured By: Akorn, Inc.
Lake Forest, IL 60045

AKP00N
Rev. 11/08

Relabeling of “Additional Barcode Label” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP

3.5 g (1/8 ounce)

BACITRACIN ZINC AND POLYMYXIN B SULFATE bacitracin zinc and polymyxin b sulfate ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1199(NDC:17478-238-35) Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 500 [USP’U] in 1 g POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [USP’U] in 1 g

Inactive Ingredients Ingredient Name Strength PETROLATUM MINERAL OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-1199-0 1 TUBE (TUBE) in 1 CARTON contains a TUBE 1 3.5 g in 1 TUBE This package is contained within the CARTON (54868-1199-0)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064028 11/12/2004

Labeler — Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 11/2010 Physicians Total Care, Inc.