Earwax Removal Drops
- Manufacturer
- Randob Labs, Ltd. | Pharma Nobis, LLC
- Effective date
- 2023-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:04:58
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DOSAGE & ADMINISTRATION SECTION
FOR USE IN THE EAR ONLY
Adults & Children over 12 yrs of age:
Tilt head to the side and place 5-10 drops into ear.
Dropper tip of removal drops 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 four days if needed, or as directed by a doctor.
Safely scoop out wax with removal tool.
Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.
Children under 12 yrs of age:
Consult a doctor.
INDICATIONS & USAGE SECTION
For occasional use as an aid to soften, loosen and remove excessive earwax.
OTC - PURPOSE SECTION
Earwax Removal Aid
OTC - ACTIVE INGREDIENT SECTION
Carbamide Peroxide 6.5%
INACTIVE INGREDIENT SECTION
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.
OTC - WHEN USING SECTION
When using this product avoid contact with eyes.
OTC - STOP USE SECTION
Stop use and ask a doctor if:
you need to use more than four days
excessive earwax remains after use of this product
OTHER SAFETY INFORMATION
Other Information
Do not use if neck wrap imprinted safety seal is broken or missing
Do not store above 25 degrees C, 77 degrees F
Store bottle in outer carton
Keep cap on bottle when not in use
Product foams on contacy with earwax due to release of oxygen
WARNINGS SECTION
Warnings
Ask a doctor before use if you have:
ear drainage or discharge
ear pain
irritation, or rash in the ear
dizziness
an injury or perforation (hole) of the eardrum
recently had ear surgery
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52412-600-05 | Earwax Removal Drops | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | 4 | |
| 52412-600-05 | Earwax Removal Drops | 1 in 1 CARTON | LIQUID | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Earwax Removal Drops
- Carbamide Peroxide 6.5%
- CHAMOMILE
- OXYQUINOLINE SULFATE
- MINERAL OIL
- ALOE VERA LEAF
- GLYCERIN
- CARBAMIDE PEROXIDE
- HYDROGEN PEROXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52412-600 | 52412-600-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHAMOMILE | FGL3685T2X | IACT |
| OXYQUINOLINE SULFATE | 61VUG75Y3P | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Earwax Removal Drops | CARBAMIDE PEROXIDE 6.5% | Randob Labs, Ltd. | a9904b63-27a4-205c-e053-2995a90af762 | 2023-12-19 | Warnings | 52412-600-05 52412-600 52412060005 0ce5bdec-f500-73d9-e063-6294a90a6a87 a9904b63-27a4-205c-e053-2995a90af762 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

