Bacitracin Zinc and Polymyxin B Sulfate

Manufacturer
A-S Medication Solutions
Effective date
2026-01-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:55:04

Label at a glance#

ProductBacitracin Zinc and Polymyxin B Sulfate
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure10 sections

Indications and uses

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

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

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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 subtilisvar Tracy. It has a potency of not less than 40 bacitracin units/mg. The structural formula for bacitracin A is:

bacitracinchemstructure
bacitracinchemstructure

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

polychemstructure
polychemstructure

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

CLINICAL PHARMACOLOGY SECTION

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosaand Haemophilus influenzaespecies.

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

INDICATIONS AND USAGE

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

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS

SPL UNCLASSIFIED 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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

Product: 50090-7189

NDC: 50090-7189-0 3.5 g in a TUBE / 144 in a CASE

Bacitracin Zinc and Polymyxin B Sulfate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN4
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD4
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00350090718904(17)991231(10)9987654(21)AA000000GTIN-14: 00350090718904
GTIN-12: 350090718904
UPC-A: 350090718904
EAN-13: 0350090718904
GTIN storage (14 digits): 00350090718904
lbl500907189.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7189-0Bacitracin Zinc and Polymyxin B Sulfate3.5 g in 1 TUBEOINTMENT3.54
50090-7189-0Bacitracin Zinc and Polymyxin B Sulfate144 in 1 CASEOINTMENT1444

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7189-0GM - Gram50090-71890aebd148-9720-4795-9c9c-07b29c41542912024-08-12
24208-555-55GM - Gram24208-555c57667c9-6de6-4089-b985-888973dbfd1112012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-718950090-7189-0
24208-555

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-07-03full-release2026-05-31 21:07:14

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATEBACITRACIN ZINC; POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-01-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-01-26c2088c7a36db…
2026-09-14 22:38:342026-08A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-01-2684e616aacf4f…
2026-08-18 06:07:402026-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICRS1995-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263f01610625f2…
2019-09-15 20:21 UTC2019-09A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064046-001BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICATRS1995-01-263a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064046-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064046-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064046-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064046-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064046-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064046-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064046-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064046-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064046-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064046-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064046-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064046-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064046-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064046-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064046-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064046-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064046-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064046-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064046-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064046-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064046-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064046-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064046-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064046-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064046-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064046-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064046-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064046-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064046-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064046-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064046-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064046-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064046-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064046-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064046-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064046-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064046-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064046-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064046-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064046-001AT1cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEA-S Medication Solutions19b4cfab-5927-47c5-a032-58ab2998d9c72026-01-13Warnings, Adverse reactionsExact identifier
ndc (package): 50090-7189-0
ndc (product): 50090-7189
ndc11 (package): 50090718900
spl id: 325d8b12-136d-4848-96c5-46c8d0d2702c
spl set id: 19b4cfab-5927-47c5-a032-58ab2998d9c7
Bacitracin Zinc and Polymyxin B SulfateBACITRACIN ZINC AND POLYMYXIN B SULFATEBausch & Lomb Incorporated1b317249-30eb-4415-8a1c-cfedb4ba35492024-10-18Warnings, Adverse reactionsExact identifier
ndc (product): 24208-555

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.