Prescription Drug Information: AK-POLY-BAC

AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment
DIRECT RX

DESCRIPTION SECTION

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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:

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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 SECTION

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.

INDICATIONS & USAGE SECTION

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 SECTION

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

WARNINGS SECTION

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS SECTION

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 & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

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 17478-238-35

STORAGE:

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

Akorn

Manufactured By: Akorn, Inc.

Lake Forest, IL 60045

AKP00N

Rev. 11/08

Principal Display Panel Text for Container Label:

NDC 17478-238-35 Akorn

AK-POLY-BAC™

brand of Bacitracin Zinc and Polymyxin B Sulfate

Ophthalmic Ointment USP

For Ophthalmic Use Only. Sterile

Rx only Net Wt. 3.5 g (1/8oz.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

989
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AK-POLY-BAC
ak-poly-bac ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-989(NDC:17478-238)
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
MINERAL OIL
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-989-35 3.5 g in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064028 01/01/2014
Labeler — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 relabel (61919-989)

Revised: 01/2020 DIRECT RX

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