Active ingredient Purpose
Carbamide peroxide 6.5% Earwax removal aid
Earwax Removal Drops
- Manufacturer
- Amerisource Bergen | Product Quest Mfg.
- Effective date
- 2018-08-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:56:36
Label at a glance#
ProductEarwax Removal Drops
Active ingredientCarbamide Peroxide
Label structure6 sections
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
For occasional use as an aid to soften, loosen and remove excessive earwax
Warnings
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
OTC - WHEN USING SECTION
When using this product avoid contact with eyes
OTC - STOP USE SECTION
Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
DOSAGE & ADMINISTRATION SECTION
DirectionsFor 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.
INACTIVE INGREDIENT SECTION
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24385-502-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e62c-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24385-502-01 | Earwax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 24385-502-01 | Earwax Removal Drops | 15 mL in 1 BOTTLE | LIQUID | 15 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Earwax Removal Drops
- Carbamide Peroxide 6.5%
- Carbamide Peroxide
- HYDROGEN PEROXIDE
- ANHYDROUS CITRIC ACID
- Glycerin
- Propylene Glycol
- Sodium Lauroyl Sarcosinate
- Sodium Stannate
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 24385-502 | 24385-502-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Carbamide Peroxide | 31PZ2VAU81 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Sodium Lauroyl Sarcosinate | 632GS99618 | IACT |
| Sodium Stannate | NJ7C1V83KG | IACT |
| Water | 059QF0KO0R | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 808ca018-2972-430e-b8e4-dae7f6e8038a | e0069b55-162c-41ed-8844-d0c51dc889c2 | 2018-08-13 | Warnings | 808ca018-2972-430e-b8e4-dae7f6e8038a e0069b55-162c-41ed-8844-d0c51dc889c2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.