ERO Ear Wax Removal Kit

Manufacturer
Randob Labs | Derma Care Research Labs, LLC
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:48

Label at a glance#

ProductERO Ear Wax Removal Kit
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

OTC - PURPOSE SECTION

Earwax removal aid

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor before use if you have

  • 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

When using this product avoid contact with the eyes

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

FOR IN EAR USE ONLY. 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 bulb ear syringe. Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD2
702050carbamide peroxide 6.5 % Otic SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-175-01ERO Ear Wax Removal Kit1 in 1 CARTONLIQUID12
52412-175-01ERO Ear Wax Removal Kit15 mL in 1 BOTTLELIQUID152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-175ERO EAR WAX REMOVAL KIT (CARBAMIDE PEROXIDE 6.5%) LIQUID [RANDOB LABS]2Current NDC, 2 package rows20241217_fbf8a6f2-531d-5047-e053-6294a90aaa01.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-17552412-175-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
ERO Ear Wax Removal KitCARBAMIDE PEROXIDE 6.5%Randob Labsfbf8a6f2-531d-5047-e053-6294a90aaa012024-12-15WarningsExact identifier
ndc (package): 52412-175-01
ndc (product): 52412-175
ndc11 (package): 52412017501
spl id: 29575528-5bed-065e-e063-6394a90a4eca
spl set id: fbf8a6f2-531d-5047-e053-6294a90aaa01

Reported adverse events (FAERS/openFDA)#

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