FDA.reportPublic FDA data

SuavEar

Manufacturer
NeilMed Pharmaceuticals Inc. | NeilMed Pharmaceuticals, Inc.
Effective date
2016-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:45

Label at a glance#

ProductSuavEar
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

SuavEar

OTC - ACTIVE INGREDIENT SECTION

SuavEar active ingredientSuavEar active ingredientCarbamide Peroxide 6.5%

DOSAGE & ADMINISTRATION SECTION

For use in the ear only.

Tilt head sideways. Place 5 to 10 drops in the ear, making sure that the tip of the applicator does not enter the ear canal. Keep drops in the ear for several minutes, either by using the included ear plugs or keeping the head tilted to the side. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb. Use twice daily for up to four days, or as directed by the doctor.

Warnings

WARNINGS SECTION

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) in the eardrum
  • Recently had ear surgery

Whe using this product avoid contact with the eyes.

Stop use and ask a doctor if

  • You need to use it for more than 3 days in a row.

List of inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Oxyquinoline

Ear canal cleaning

INDICATIONS & USAGE SECTION

For occasional aid to soften, loosen and remove excessive earwax

Purpose

OTC - PURPOSE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13709-233-012020-01-31C16284748780-19d75b9d0-3ddb-f424-e053-dadaa90a57ce663bae1b-c8e3-104a-e053-2991aa0a4edf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-233-01SuavEar15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-233SUAVEAR SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC.]1Legacy NDC, 1 package rows20180301_663bae1b-c8e3-104a-e053-2991aa0a4edf.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-23313709-233-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
GLYCERINPDC6A3C0OXIACT
OXYQUINOLINE5UTX5635HPIACT

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
663bae1b-c8e4-104a-e053-2991aa0a4edf663bae1b-c8e3-104a-e053-2991aa0a4edf2016-03-09WarningsExact identifier
spl id: 663bae1b-c8e4-104a-e053-2991aa0a4edf
spl set id: 663bae1b-c8e3-104a-e053-2991aa0a4edf

Reported adverse events (FAERS/openFDA)#

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