Prescription Drug Information: Bacitracin Zinc and Polymyxin B Sulfate

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

Bacitracin A (Strucural Formula)

Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , 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:

Polymyxin B Sulfate (Structural Formula)
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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

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP is available in tubes with an ophthalmic tip applicator in the following size:

Box of 3.5g NDC 68071-5267-3

Storage

Store between 15° to 25°C (59° to 77°F). KEEP TIGHTLY CLOSED

Keep out of reach of children.

Distributed by:

Bausch + Lomb, a division of Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured by:

Bausch & Lomb Incorporated

Tampa, FL 33637 USA

© 2020 Bausch & Lomb Incorporated or its affiliates

Revised: February 2020

9130703 (Folded)

9130603 (Flat)

PRINCIPAL DISPLAY PANEL

pdp
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BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-5267(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:68071-5267-3 3.5 g in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064046 04/25/2008
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-5267)

Revised: 06/2020 NuCare Pharmaceuticals,Inc.

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