Ear Wax Remover

Manufacturer
Proficient Rx LP
Effective date
2021-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:55:56

Label at a glance#

ProductEar Wax Remover
Active ingredientCARBAMIDE PEROXIDE
Label structure9 sections

Indications and uses

Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

Dosage and administration

Directions FOR USE IN THE EAR ONLY Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle. 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 d...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION



Active ingredient                                    Purpose

Carbamide Peroxide 6.5%..........................Earwax Removal Aid


Uses

OTC - PURPOSE SECTION



Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

Keep Out of Reach of Children

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 right away.

Indications and Usage

INDICATIONS & USAGE SECTION


Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.

Warnings

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 ear drum
- recently had ear surgery

Stop use and ask a doctor if
- you need to use for more than four days
- excessive wax remains after use of this product

When using this product - avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult your doctor.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Directions
FOR USE IN THE EAR ONLY


Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.

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 ear syringe.
- when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal

Children under 12 years of age: consult a doctor.

Other information
- avoid exposing the bottle to excessive heat and direct sunlight
- keep cap on bottle when not in use
- lot no. & exp date: see label, bottom of container or box
- retain carton for future reference on full labeling
- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound
- Note: Oversize packaging for ease in reading label information. Contains one bottle.
- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION



Inactive ingredients

anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid

Questions?

SPL UNCLASSIFIED SECTION

 Adverse Drug Event Call toll free: (800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63187-187-15

EAR WAX REMOVER
WITH IRRIGATOR
Earwax Removal Aid
(carbamide peroxide 6.5%)

Distributed by:

MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150  USA

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

63187-187-15
63187-187-15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6004-35ML - Milliliter0904-6004ff0b0eb1-1f79-4225-91a1-e44e63a5f4d312013-04-01

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
63187-18763187-187-15
0904-6004

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
6a4639c2-37ba-4574-b7ef-5e46822577cacd054ea1-2bfa-4814-bd88-618c4b8f04b52024-10-01WarningsExact identifier
spl set id: cd054ea1-2bfa-4814-bd88-618c4b8f04b5

Reported adverse events (FAERS/openFDA)#

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