FDA.reportPublic FDA data

Equaline Earwax Removal Drops

Manufacturer
United Natural Foods | Bell Pharmaceuticals, Inc.
Effective date
2025-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:29

Label at a glance#

ProductEqualine Earwax Removal Drops
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

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 remainig after treatment may be removed by gently flushing the ear with warm water...

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 before use if you have

OTC - ASK DOCTOR SECTION

  • ear drainage or discharge
  • ear pain
  • irritation, or rash in the ear
  • dizziness
  • an injury or perforation (hole) of the ear drum
  • 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 4 days
  • excessive earwax remains after use of this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 remainig after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

Children under 12 years: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Do not store above 25°C (77°F)
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-855-423-2630

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD3
702050carbamide peroxide 6.5 % Otic SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-835-34Equaline Earwax Removal Drops15 mL in 1 BOTTLELIQUID153
41163-835-34Equaline Earwax Removal Drops1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-835EQUALINE EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [UNITED NATURAL FOODS]3Current NDC, Legacy NDC, 2 package rows20250303_d853567a-ce8d-40a8-be1e-27176802ff64.zip

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
41163-83541163-835-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
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
Equaline Earwax Removal DropsCARBAMIDE PEROXIDEUnited Natural Foodsd853567a-ce8d-40a8-be1e-27176802ff642025-02-28WarningsExact identifier
ndc (package): 41163-835-34
ndc (product): 41163-835
ndc11 (package): 41163083534
spl id: 2f398b89-ffb2-5b80-e063-6394a90ac5f3
spl set id: d853567a-ce8d-40a8-be1e-27176802ff64

Reported adverse events (FAERS/openFDA)#

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