Indications and uses
First aid to help prevent infection in minor cuts, scrapes, and burns.
First aid to help prevent infection in minor cuts, scrapes, and burns.
clean affected area apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily may cover with a sterile bandage
Drug Facts
Bacitracin zinc (500 units bacitracin)
First Aid Antibiotic
First aid to help prevent infection in minor cuts, scrapes, and burns.
For external use only. Keep out of reach of children.
If ingested, get medical help or contact a Poison Control Center directly.
mineral oil, petrolatum
1-800-456-7077
NDC 61010-5601-2
Safetec
First Aid
Single Antibiotic Ointment
• with Bacitracin
• First Aid to Help Prevent
Infection In Minor Cuts,
Scrapes, and Burns
Reorder No. 53310
To reorder:
Call: 1-800-456-7077
Fax: 716-895-2969
Online:
www.safetec.com

| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2d352c73-a357-4193-a4de-dfdf9a2ac8e4 | Product name | 1 | 20150819 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61010-5601 | 61010-5601-1, 61010-5601-2, 61010-5601-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| BACITRACIN ZINC | 89Y4M234ES | ACTIM |
| MINERAL OIL | T5L8T28FGP | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2024-02-14 | full-release | 2026-06-01 00:08:38 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| Single Antibiotic with bacitracin | BACITRACIN ZINC | Safetec of America | 4ae9a105-e3f9-4015-8844-085e0b34cdb6 | 2026-06-25 | Warnings | 61010-5601-1 61010-5601-2 61010-5601-3 61010-5601 61010560103 61010560102 61010560101 55135000-91eb-c54b-e063-6394a90afdcd 4ae9a105-e3f9-4015-8844-085e0b34cdb6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.