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#

ProductEarwax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

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

ERO Label.jpgERO Label.jpgERO IFC.jpgERO IFC.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-600-05Earwax Removal Drops15 mL in 1 BOTTLE, DROPPERLIQUID154
52412-600-05Earwax Removal Drops1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-600EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [RANDOB LABS, LTD.]4Current NDC, Legacy NDC, 2 package rows20231220_a9904b63-27a4-205c-e053-2995a90af762.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-60052412-600-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Randob Labs, Ltd.a9904b63-27a4-205c-e053-2995a90af7622023-12-19WarningsExact identifier
ndc (package): 52412-600-05
ndc (product): 52412-600
ndc11 (package): 52412060005
spl id: 0ce5bdec-f500-73d9-e063-6294a90a6a87
spl set id: a9904b63-27a4-205c-e053-2995a90af762

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.