OTC - ACTIVE INGREDIENT SECTION
Carbamide Peroxide 6.5%
Carbamide Peroxide 6.5%
Earwax Removal Aid
For occasional use as an aid to soften. loosen and remove excessive earwax.
Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery
When using this product avoid contact with eyes
Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product
Stop use and ask a doctor if you need to use for more than four days • excessive earwax remains after use of this product
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
Directions- For use in the ear only.
Adults and children over 12 years of age:
• tilt head sideways and place 5 to 10 drops into ear
• tip of applicator should not enter ear canal
• keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
• use twice daily for up to 4 days if needed, or as directed by a doctor
• any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
Children under 12 years of age: consult a doctor.
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
If swallowed, get medical help or contact a Poison Control Center right away.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-5273-0 | 2024-01-08 | C162847 | 48780-1 | f386c64a-18ea-0266-e053-dadaa90a7c1a | Ear Drops Major |
| 50090-5273-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-18ea-0266-e053-dadaa90a7c1a | Ear Drops Major |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-5273-0 | Ear DropsMajor | 15 mL in 1 BOTTLE | LIQUID | 15 | 6 | |
| 50090-5273-0 | Ear DropsMajor | 1 in 1 CARTON | LIQUID | 1 | 6 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-5273 | EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [A-S MEDICATION SOLUTIONS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240109_eb7df1cc-50db-479a-bc1c-dfd7004dd35b.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-5273-0 | ML - Milliliter | 50090-5273 | 53def603-5221-484a-9ef1-47c7a5342882 | 1 | 2023-02-06 |
| 0904-6627-35 | ML - Milliliter | 0904-6627 | 961d332f-97a9-4b3c-bf08-36c272f44857 | 1 | 2017-08-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-5273 | 50090-5273-0 |
| 0904-6627 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM STANNATE | NJ7C1V83KG | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM LAUROYL SARCOSINATE | 632GS99618 | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Ear Drops Major | CARBAMIDE PEROXIDE 6.5% | Major Pharmaceuticals | ad8bce05-6be4-4f6c-9341-bce7c3aa05cf | 2025-07-28 | Warnings | 0904-6627 |
| Ear Drops Major | CARBAMIDE PEROXIDE 6.5% | A-S Medication Solutions | eb7df1cc-50db-479a-bc1c-dfd7004dd35b | 2024-01-08 | Warnings | 50090-5273-0 50090-5273 50090527300 bac0c4d3-f01c-4ade-a739-51480e272328 eb7df1cc-50db-479a-bc1c-dfd7004dd35b |
Adverse event summaries are temporarily unavailable. Other product information remains available.