Bacitracin Zinc and Polymyxin B Sulfate

BACITRACIN ZINC AND POLYMYXIN B SULFATE- bacitracin zinc and polymyxin b sulfate ointment
RPK Pharmaceuticals, Inc.

Rx only

DESCRIPTION

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is a sterile antimicrobial ointment formulated 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/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/mg, calculated on an anhydrous basis. The structural formulae are:

Each gram contains: Actives: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; Inactives: Mineral Oil and White Petrolatum.

CLINICAL PHARMACOLOGY

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

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

INDlCATlONS 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.

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

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

FOR OPHTHALMIC USE ONLY

HOW SUPPLIED

Product: 53002-9271

NDC: 53002-9271-1 3.5 g in a BOTTLE, DROPPER

Bacitracin/Poly-B Ophthalmic Ointment

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53002-9271(NDC:24208-555) Route of Administration OPHTHALMIC DEA Schedule

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

Inactive Ingredients Ingredient Name Strength PETROLATUM MINERAL OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53002-9271-1 3.5 g in 1 BOTTLE, DROPPER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA064046 04/25/2008

Labeler — RPK Pharmaceuticals, Inc. (147096275)

Establishment
Name	Address	ID/FEI	Operations
RPK Pharmaceuticals, Inc.		147096275	RELABEL (53002-9271), REPACK (53002-9271)

Revised: 12/2020 RPK Pharmaceuticals, Inc.