Ear Drops

Manufacturer
A-S Medication Solutions
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:06:51

Label at a glance#

ProductEar Drops Major
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 doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

When using this product avoid contact with eyes

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

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

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

DOSAGE & ADMINISTRATION SECTION

Directions- For use in the ear 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

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Carbamide Peroxide 6.5%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN6
702050carbamide peroxide 65 MG/ML Otic SolutionSCD6
702050carbamide peroxide 6.5 % Otic SolutionSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5273-02024-01-08C16284748780-1f386c64a-18ea-0266-e053-dadaa90a7c1aEar Drops Major
50090-5273-02023-01-30C16284748780-1f386c64a-18ea-0266-e053-dadaa90a7c1aEar Drops Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5273-0Ear DropsMajor15 mL in 1 BOTTLELIQUID156
50090-5273-0Ear DropsMajor1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5273EAR DROPS MAJOR (CARBAMIDE PEROXIDE 6.5%) LIQUID [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240109_eb7df1cc-50db-479a-bc1c-dfd7004dd35b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5273-0ML - Milliliter50090-527353def603-5221-484a-9ef1-47c7a534288212023-02-06
0904-6627-35ML - Milliliter0904-6627961d332f-97a9-4b3c-bf08-36c272f4485712017-08-11

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
50090-527350090-5273-0
0904-6627

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ear Drops MajorCARBAMIDE PEROXIDE 6.5%Major Pharmaceuticalsad8bce05-6be4-4f6c-9341-bce7c3aa05cf2025-07-28WarningsExact identifier
ndc (product): 0904-6627
Ear Drops MajorCARBAMIDE PEROXIDE 6.5%A-S Medication Solutionseb7df1cc-50db-479a-bc1c-dfd7004dd35b2024-01-08WarningsExact identifier
ndc (package): 50090-5273-0
ndc (product): 50090-5273
ndc11 (package): 50090527300
spl id: bac0c4d3-f01c-4ade-a739-51480e272328
spl set id: eb7df1cc-50db-479a-bc1c-dfd7004dd35b

Reported adverse events (FAERS/openFDA)#

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