Indications and uses
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
This product should not be used in patients with a history of hypersensitivity to Bacitracin.
Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.
Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.
To report SUSPECTED ADVERSE REACTIONS, contact Padagis® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.
NDC 0574-4022-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Manufactured for Padagis® by Jubilant HollisterStier General Partnership
Kirkland, Quebec H9H 4J4 Canada
35F00 RC PH2
Rev 02-23
NDC 0574-4022-35
Rx Only
Bacitracin Ophthalmic Ointment USP
NET WT 3.5 g (1/8 oz)
STERILE

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0574-4022-11 | GM - Gram | 0574-4022 | 4ba319ca-13c5-4089-926f-7917712e1057 | 1 | 2014-09-03 |
| 0574-4022-13 | GM - Gram | 0574-4022 | 537247dc-4a7a-4c79-83e3-c2f3e6a60040 | 1 | 2014-09-03 |
| 0574-4022-35 | GM - Gram | 0574-4022 | 8531c58e-456b-4288-9794-b153dd9c5128 | 1 | 2014-04-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BACITRACIN | ACTIVE INGREDIENT | 58H6RWO52I | 1 | |
| BACITRACIN | ACTIVE MOIETY | 58H6RWO52I | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0574-4022 | 0574-4022-11, 0574-4022-01, 0574-4022-13, 0574-4022-35 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BACITRACIN | 58H6RWO52I | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061212-001 | BACITRACIN | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A061212-001 | BACITRACIN | 500 UNITS/GM | OINTMENT / OPHTHALMIC | RS, Approved before 1982 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| 7f0a3025-0a9b-4977-8c3f-f78e4b4b19a3 | 6ed2f2bd-9d2f-46af-a44c-95a02ca034de | 2024-10-31 | Adverse reactions | 6ed2f2bd-9d2f-46af-a44c-95a02ca034de |