ProRinse Earwax Removal System

Manufacturer
McKeon Products Inc | Bell Pharmaceuticals, Inc.
Effective date
2026-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:37:47

Label at a glance#

ProductProRinse Earwax Removal System
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and Children over 12 years of age: Tilt head sideways and place 5 to 10 Earwax Removal Drops into ear Tip of applicator nozzle should NOT enter ear canal With head still sideways, insert earplugs as follows: Reach over head and pull up and back on outer ear to straighten ear canal With opposite hand, grasp earplug stem and insert by pressing forward in a circular motion, just enough to seal in drops. Do not...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For use in the ear only

Ask a doctor or pharmacist before use if you have:

  • ear drainage or discharge
  • recently had ear surgery
  • dizziness
  • pain, irritation, or rash in the ear
  • an ear infection
  • had an injury or perforation (hole) of the eardrum

Stop use and ask doctor if:

  • you need to use for more than four days
  • excessive earwax remains after use of this product

When using this product, avoid contact with the eyes

When using earplugs, do not insert deeply into ear canal. Remove very slowly with a twisting motion to gradually break the seal. Due to the excellent seal characteristics, rapid removal may damage eardrum

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years of age:

  • Tilt head sideways and place 5 to 10 Earwax Removal Drops into ear

Tip of applicator nozzle should NOT enter ear canal

  • With head still sideways, insert earplugs as follows:

Reach over head and pull up and back on outer ear to straighten ear canal

With opposite hand, grasp earplug stem and insert by pressing forward in a circular motion, just enough to seal in drops. Do not insert deeply into canal.

  • Repeat for other ear, if treating both ears
  • Keep drops in ear(s) for several minutes
  • Remove earplugs slowly with a twisting motion to gradually break the seal
  • Use twice daily for up to four days if needed, or as directed by a doctor
  • Any earwax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water, using the Bellow Syringe

Fill supplied tub 1/3 to 1/2 full with body-temperature water

Fully compress Bellow Syringe and insert blue Rinse Tip into water

Release the pressure on the Bellow Syringe, allowing the water to be drawn into the bellow

While holding tub beneath ear, place the blue Rinse Tip into ear opening and compress bellow to rinse ear canal

Children under 12 years of age: Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Avoid exposing Earwax Removal Drops to excessive heat and sunlight
  • Ear drops foam on contact with earwax due to release of oxygen. There may be an associated “crackling” sound
  • Keep cap on bottle when not in use
  • This system is designed for multiple treatments
  • The components are washable and reusable

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions or comments?

OTC - QUESTIONS SECTION

Call (586) 427-7560 during business hours (EST)

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN1
702050carbamide peroxide 65 MG/ML Otic SolutionSCD1
702050carbamide peroxide 6.5 % Otic SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66354-007-82ProRinse Earwax Removal System15 mL in 1 BOTTLESOLUTION/ DROPS151
66354-007-82ProRinse Earwax Removal System1 in 1 BOXSOLUTION/ DROPS11

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
66354-00766354-007-82

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
ProRinse Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Incca82db28-1ef7-41c6-a46b-7bfc7b09281c2026-02-09WarningsExact identifier
ndc (package): 66354-007-82
ndc (product): 66354-007
ndc11 (package): 66354000782
spl id: 4a636cb5-104c-7811-e063-6294a90afcb0
spl set id: ca82db28-1ef7-41c6-a46b-7bfc7b09281c

Reported adverse events (FAERS/openFDA)#

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