Label: AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 8, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Rx only

  • DESCRIPTION:

    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:

    Structural 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:

    Structural Formula

    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.

  • 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 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. 06/16

  • PRINCIPAL DISPLAY PANEL

    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 (1/8 oz)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-238-35

    AK-POLY-BAC™

    brand of Bacitracin Zinc and Polymyxin B Sulfate

    Ophthalmic Ointment, USP

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

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    AK-POLY-BAC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-238
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17478-238-351 in 1 CARTON05/08/2006
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06402805/08/2006
    Labeler - Akorn (117696770)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE(17478-238) , ANALYSIS(17478-238) , STERILIZE(17478-238) , PACK(17478-238) , LABEL(17478-238)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!