Earwax Removal Drops

Manufacturer
Humco Holding Group, Inc | Pharma Nobis, LLC
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:37

Label at a glance#

ProductEarwax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Adults & Children over 12 yrs of age:

tilt head to the side and place 10 drops into the ear canal.

Tip of applicator should not enter into the ear canal

Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age:

Consult a physician.

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen and remove excessive earwax.

OTC - PURPOSE SECTION

Earwax Removal Aid

WARNINGS SECTION

Warnings

For external use only

Ask a doctor before use if you have:

ear drainage or discharge

ear pain, irritation, or rash in the ear

recently had surgery

dizziness

an injury or perforation (hole) of the eardrum

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

Purified Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

murmur

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91320395-9132-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
0d99ad33-6033-1d16-e063-6294a90a1ee2a8bfdc6d-5679-432a-e053-2995a90ad3802023-12-28WarningsExact identifier
spl id: 0d99ad33-6033-1d16-e063-6294a90a1ee2
spl set id: a8bfdc6d-5679-432a-e053-2995a90ad380

Reported adverse events (FAERS/openFDA)#

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