OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Purpose
SODIUM BORATE .............................. Antifungal
Glycerin ................................................. Moisturizer
Active Ingredients Purpose
SODIUM BORATE .............................. Antifungal
Glycerin ................................................. Moisturizer
Use
May help aliviate mouth ulcers
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Antifuncgal
For External Use Only
Directions
Warnings For external use only
Avoid Contact with eyes.
When using this product
Stop use and ask a doctor if condition persists or gets worse
Inactive Ingredients Extract of Roses, Honey , FD&C red # 40, Purified Water
| Class | Version | Type | Effective |
|---|---|---|---|
| GLYCERIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70242-127-01 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-411a-f424-e053-dadaa90a57ce | Miel Rosada |
| 70242-127-01 | 2023-11-14 | C162847 | 48780-1 | 9d75b9d0-411a-f424-e053-dadaa90a57ce | Miel Rosada |
| 70242-127-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-411a-f424-e053-dadaa90a57ce | Miel Rosada |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70242-127-01 | Miel Rosada | 30 mL in 1 BOTTLE, PLASTIC | SOLUTION | 30 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70242-127 | 70242-127-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BORATE | 91MBZ8H3QO | ACTIB |
| GLYCERIN | PDC6A3C0OX | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| HONEY | Y9H1V576FH | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 1a368815-91d9-41ba-aa3e-809ee1b2e4ce | 362f20d7-3fd1-4e46-8c90-155457105ac3 | 2023-01-01 | Warnings | 1a368815-91d9-41ba-aa3e-809ee1b2e4ce 362f20d7-3fd1-4e46-8c90-155457105ac3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.