Boxed warning
Drug Facts Label.jpg
Drug Facts Label.jpg
Drug Facts Label.jpg
This product is only being produced for export and according to email received by FDA, there are no labeling requirements. This is what I received: "When listing an export only item, please use the marketing category, ‘Export only’. This will exempt your content of labeling from U.S. labeling requirements."
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76531-202-00 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3189-111a-e063-dadaa90a10e2 | a49d504b-b807-777d-e053-2a95a90a767a |
| 76531-202-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3189-111a-e063-dadaa90a10e2 | a49d504b-b807-777d-e053-2a95a90a767a |
| 76531-202-07 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3189-111a-e063-dadaa90a10e2 | a49d504b-b807-777d-e053-2a95a90a767a |
| 76531-202-50 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3189-111a-e063-dadaa90a10e2 | a49d504b-b807-777d-e053-2a95a90a767a |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76531-202 | 76531-202-01, 76531-202-07, 76531-202-50, 76531-202-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| CHAMOMILE | FGL3685T2X | IACT |
| WATER | 059QF0KO0R | IACT |
| ALOE | V5VD430YW9 | IACT |
| LAVANDULA ANGUSTIFOLIA FLOWER | 19AH1RAF4M | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
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 |
|---|---|---|---|---|---|---|
| 12f14093-bddf-451e-e063-6394a90a43e3 | a49d504b-b807-777d-e053-2a95a90a767a | 2024-03-05 | Warnings | a49d504b-b807-777d-e053-2a95a90a767a |
Adverse event summaries are temporarily unavailable. Other product information remains available.