Dosage and administration
• clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage
• clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage
• store at 20-25°C (68-77°F)
Bacitracin zinc equivalent to 400 units bacitracin
Neomycin sulfate equivalent to 3.5 mg of neomycin base
Polymyxin B 5,000 units as polymyxin B sulfate
First aid antibiotic
first aid to help prevent infection in minor:
For external use only.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum
1-800-719-9260
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | 4 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 4 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 4 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BACITRACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NEOMYCIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POLYMYXIN B Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 2d352c73-a357-4193-a4de-dfdf9a2ac8e4 | Product name | 1 | 20150819 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-263-64 | Triple Antibiotic | 1 in 1 CARTON | OINTMENT | 1 | 4 | |
| 37808-263-64 | Triple Antibiotic | 28 g in 1 TUBE | OINTMENT | 28 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BACITRACIN ZINC | ACTIVE INGREDIENT | 89Y4M234ES | 2 | |
| NEOMYCIN SULFATE | ACTIVE INGREDIENT | 057Y626693 | 2 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | 2 | |
| BACITRACIN | ACTIVE MOIETY | 58H6RWO52I | 2 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | 2 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| COCOA BUTTER | INACTIVE INGREDIENT | 512OYT1CRR | 2 | |
| COTTONSEED OIL | INACTIVE INGREDIENT | H3E878020N | 2 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 2 | |
| SODIUM PYRUVATE | INACTIVE INGREDIENT | POD38AIF08 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37808-263 | 37808-263-64 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BACITRACIN ZINC | 89Y4M234ES | ACTIM |
| NEOMYCIN SULFATE | 057Y626693 | ACTIM |
| POLYMYXIN B SULFATE | 19371312D4 | ACTIM |
| COCOA BUTTER | 512OYT1CRR | IACT |
| COTTONSEED OIL | H3E878020N | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| SODIUM PYRUVATE | POD38AIF08 | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| PETROLATUM | 4T6H12BN9U | 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 |
|---|---|---|---|---|---|---|
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | INJECTION, SOLUTION / INTRAMUSCULAR | 1120 mg | ||
| COCOA BUTTER | COCOA BUTTER | 512OYT1CRR | SUPPOSITORY / RECTAL | 2280 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOAP / TOPICAL | NA | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | INJECTION / INTRAMUSCULAR | 1084 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / TOPICAL | 0.6 %w/w | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | SPRAY, METERED / NASAL | 1.33 mg/0.1ml | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | INJECTION, SOLUTION / INTRAMUSCULAR | 1120 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| COCOA BUTTER | COCOA BUTTER | 512OYT1CRR | SUPPOSITORY / RECTAL | 2280 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | CAPSULE / ORAL | NA | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / TOPICAL | 0.6 %w/w | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOAP / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | SPRAY, METERED / NASAL | 1.33 mg/0.1ml | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | CAPSULE / ORAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | INJECTION / INTRAMUSCULAR | 1084 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | TABLET / ORAL | 0.16 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | TABLET / ORAL | 0.16 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg |
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 |
|---|---|---|---|---|---|---|---|
| N000004-004 | PAREDRINE | HYDROXYAMPHETAMINE HYDROBROMIDE | 1% | SOLUTION/DROPS / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | H E B | 58a4d263-e234-43cd-a3bd-b19a492174d9 | 2024-10-11 | Warnings | 37808-263-64 37808-263 37808026364 be02d97b-a643-4cb8-8038-7ffe68aa4096 58a4d263-e234-43cd-a3bd-b19a492174d9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.