Prescription Drug Information: Bacitracin Zinc and Polymyxin B Sulfate

BACITRACIN ZINC AND POLYMYXIN B SULFATE- bacitracin zinc and polymyxin b sulfate ointment
Rebel Distributors Corp

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 per mg. The structural formula for bacitracin A is:

Bacitracin A (Strucural Formula)

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:

Polymyxin B Sulfate (Structural Formula)
(click image for full-size original)

Each Gram Contains: ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum and Mineral Oil.

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.

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:

3.5 gram tube — NDC 42254-154-35

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

Storage:

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

KEEP OUT OF REACH OF CHILDREN.

Revised November 2007

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9130700 (Folded)
9130600 (Flat)

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

Bacitracin Zinc/Polymyxin B 500/10,000 Units
(click image for full-size original)

BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-154(NDC:24208-555)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 500 in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-154-35 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (42254-154-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064046 04/25/2008
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2012 Rebel Distributors Corp

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.