Bacitracin Ophthalmic Ointment USP

Manufacturer
Padagis US LLC
Effective date
2024-10-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:50:39

Label at a glance#

ProductBacitracin
Active ingredientBACITRACIN
Label structure9 sections

Indications and uses

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

Dosage and administration

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.

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

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.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

This product should not be used in patients with a history of hypersensitivity to Bacitracin.

PRECAUTIONS:

PRECAUTIONS SECTION

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.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED:

HOW SUPPLIED SECTION

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

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0574-4022-35

Rx Only

Bacitracin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 oz)

STERILE

Bacitracin Ophthalmic Ointment carton
Bacitracin Ophthalmic Ointment carton

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.

serialization-template
serialization-template

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4022BACITRACIN OINTMENT [PADAGIS US LLC]6Legacy NDC20241102_6ed2f2bd-9d2f-46af-a44c-95a02ca034de.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4022-11GM - Gram0574-40224ba319ca-13c5-4089-926f-7917712e105712014-09-03
0574-4022-13GM - Gram0574-4022537247dc-4a7a-4c79-83e3-c2f3e6a6004012014-09-03
0574-4022-35GM - Gram0574-40228531c58e-456b-4288-9794-b153dd9c512812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52I1
BACITRACINACTIVE MOIETY58H6RWO52I1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0574-40220574-4022-11, 0574-4022-01, 0574-4022-13, 0574-4022-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN58H6RWO52IACTIB
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

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 1.

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
A061212-001BACITRACINBACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICApproved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061212-001BACITRACIN500 UNITS/GMOINTMENT / OPHTHALMICRS, Approved before 1982cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7f0a3025-0a9b-4977-8c3f-f78e4b4b19a36ed2f2bd-9d2f-46af-a44c-95a02ca034de2024-10-31Adverse reactionsExact identifier
spl set id: 6ed2f2bd-9d2f-46af-a44c-95a02ca034de