Drug Facts Box OTC-Active Ingredient Section
Chloroxylenol 0.3%
Chloroxylenol 0.3%
Antiseptic
for hand-washing to decrease bacteria on the skin
For external use only
do not get into eyes
if contact occurs, rinse eyes thoroughly with water
irritation and redness develop
if swallowed, get medical help or contact a Poison Control Center right away
water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, FD&C RED NO. 40
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75632-876-14 | Freshands Premium Foamy Antibacterial Handsoap 6876 | 3785 mL in 1 BOTTLE, PLASTIC | SOAP | 3785 | 5 | |
| 75632-876-17 | Freshands Premium Foamy Antibacterial Handsoap 6876 | 532 mL in 1 BOTTLE, PLASTIC | SOAP | 532 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75632-876 | 75632-876-14, 75632-876-17 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM LAURETH SULFATE | BPV390UAP0 | IACT |
| DECYL GLUCOSIDE | Z17H97EA6Y | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLCHLOROISOTHIAZOLINONE | DEL7T5QRPN | IACT |
| METHYLISOTHIAZOLINONE | 229D0E1QFA | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CHLOROXYLENOL | 0F32U78V2Q | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-11-20 | monthly-update | 2026-06-03 17:40:25 |
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 |
|---|---|---|---|---|---|---|
| Freshands Premium Foamy Antibacterial Handsoap 6876 | CHLOROXYLENOL | Consolidated Chemicals, LLC | f17299a4-28d6-e65b-e053-2a95a90a05e7 | 2026-05-11 | Warnings | 75632-876-17 75632-876-14 75632-876 75632087617 75632087614 518de3d7-3879-079d-e063-6394a90a50c0 f17299a4-28d6-e65b-e053-2a95a90a05e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.