FDA.reportPublic FDA data

SuavEar Earwax Removal Aid

Manufacturer
NEILMED PHARMACEUTICALS INC
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:05

Label at a glance#

ProductSuavEar Earwax Removal Aid
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

FOR USE IN THE EAR ONLY Adults and children 12 years of age: Tilt head sideways Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal Keep drops in the ear for sevaral minutes, either by using teh included earplugs 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 ...

Storage and handling

Store bottle in the outer carton Product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound. Keep cap on bottle when not in use

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

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 eardrum
  • Recently had ear surgery

When using this product

OTC - WHEN USING SECTION

Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep this and all drugs out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY

Adults and children 12 years of age:

  • Tilt head sideways
  • Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal
  • Keep drops in the ear for sevaral minutes, either by using teh included earplugs 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 upto four days, or as directed by a doctor

Children under 12 years: consult a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Store bottle in the outer carton
  • Product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound.
  • Keep cap on bottle when not in use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin

Oxyquinoline

Product label : SuavEar Earwax Removal Aid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SuavearSuavear

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN2
2540674SuavEar Earwax Removal Aid 6.5 % Otic SolutionPSN2
2540674carbamide peroxide 65 MG/ML Otic Solution [Suavear]SBD2
702050carbamide peroxide 65 MG/ML Otic SolutionSCD2
702050carbamide peroxide 6.5 % Otic SolutionSY2
2540674SuavEar 6.5 % Otic SolutionSY2
2540674SuavEar 65 MG/ML Otic SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-312-01SuavEar Earwax Removal Aid15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
13709-312-01SuavEar Earwax Removal Aid1 in 1 KITSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-312SUAVEAR EARWAX REMOVAL AID (EARWAX REMOVAL AID) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20240112_c067f1a4-1f67-3f4d-e053-2a95a90a6095.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-31213709-312-01

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
GLYCERINPDC6A3C0OXIACT
OXYQUINOLINE5UTX5635HPIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

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
SuavEar Earwax Removal AidEARWAX REMOVAL AIDNEILMED PHARMACEUTICALS INCc067f1a4-1f67-3f4d-e053-2a95a90a60952024-01-11WarningsExact identifier
ndc (package): 13709-312-01
ndc (product): 13709-312
ndc11 (package): 13709031201
spl id: 0eb0ee15-bb9f-bd77-e063-6394a90a0df7
spl set id: c067f1a4-1f67-3f4d-e053-2a95a90a6095

Reported adverse events (FAERS/openFDA)#

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