OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Carbamide Peroxide 6.5%
Active Ingredient
Carbamide Peroxide 6.5%
Purpose
Carbamide Peroxide 6.5%
Uses
For occasional use as an aid to soften, loosen, and remove excessive ear wax.
Warnings
Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor. If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor. For more than four consecutive days.
When using this product: avoid contact with the eyes.
Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.
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 ear. Use twice daily for up to four 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.
Inactive ingredients
Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil
Ear Wax Cleansing Kit
Step 1 Ear Wax Removing Drops
Step 2 Ear Cleansing Spray
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37205-615-56 | 2025-04-22 | C162847 | 48780-1 | 9d75b9d0-f8cb-f424-e053-dadaa90a57ce | Drug Facts |
| 37205-615-56 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f8cb-f424-e053-dadaa90a57ce | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Carbamide Peroxide | ACTIVE INGREDIENT | 31PZ2VAU81 | 1 | |
| Carbamide Peroxide | ACTIVE MOIETY | 31PZ2VAU81 | 1 | |
| Aloe Vera Leaf | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| CHAMAEMELUM NOBILE FLOWER OIL | INACTIVE INGREDIENT | UB27587839 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37205-615 | 37205-615-56 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carbamide Peroxide | 31PZ2VAU81 | ACTIB |
| Aloe Vera Leaf | ZY81Z83H0X | IACT |
| CHAMAEMELUM NOBILE FLOWER OIL | UB27587839 | 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 |
|---|---|---|---|---|---|---|
| faf79d2a-fede-4408-b31a-ccfe13fde47f | 1a1523f0-9d65-44de-afab-a0df6faebb8a | 2025-04-16 | Warnings | 1a1523f0-9d65-44de-afab-a0df6faebb8a |
Adverse event summaries are temporarily unavailable. Other product information remains available.