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.
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2017-12-19
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:06:00
Label at a glance#
ProductAK-POLY-BAC
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure11 sections
Dosage and administration
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Storage and handling
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
Label contents#
Full prescribing information#
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:
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:
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:
Product: 50090-0447
NDC: 50090-0447-0 3.5 g in a TUBE
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
Bacitracin Zinc and Polymyxin B Sulfate
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-238-35 | GM - Gram | 17478-238 | 18c4098a-02ad-4932-823e-5e791bce449d | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- AK-POLY-BAC
- Bacitracin Zinc and Polymyxin B Sulfate
- BACITRACIN ZINC
- BACITRACIN
- POLYMYXIN B SULFATE
- POLYMYXIN B
- Mineral Oil
- Petrolatum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-0447 | 50090-0447-0 |
| 17478-238 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BACITRACIN ZINC | 89Y4M234ES | ACTIM |
| POLYMYXIN B SULFATE | 19371312D4 | ACTIM |
| Mineral Oil | T5L8T28FGP | IACT |
| Petrolatum | 4T6H12BN9U | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | 1995-01-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064028-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | 1995-01-30 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064028-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064028-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064028-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064028-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064028-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064028-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064028-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064028-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064028-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064028-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064028-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064028-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064028-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064028-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064028-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064028-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064028-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064028-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064028-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064028-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064028-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064028-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064028-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064028-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064028-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064028-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064028-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064028-001 | AT | 1 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 71f22077-b18d-4d51-871c-e0c69f44fc3b | 9d7a5fb6-ad90-43e2-9734-d165ab19da73 | 2017-12-19 | Warnings | 71f22077-b18d-4d51-871c-e0c69f44fc3b 9d7a5fb6-ad90-43e2-9734-d165ab19da73 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.