FDA.reportPublic FDA data

HealthMart Earwax Removal Kit Ear wax drops and Bulb

Manufacturer
McKesson Corp via Strategic Sourcing Services LLC | Bell Pharmaceuticals, Inc.
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:41:45

Label at a glance#

ProductHealthMart Earwax Removal Kit Ear wax drops and Bulb
Active ingredientCARBAMIDE PEROXIDE
Label structure16 sections

Indications and uses

for occasional use as an aid to soften, loosen, and remove excessive ear wax

Dosage and administration

FOR USE IN THE EAR ONLY Adults and children over 12 years of age: consult a doctor Children under 12 years: 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Ear wax removal aid

Uses

INDICATIONS & USAGE SECTION

for occasional use as an aid to soften, loosen, and remove excessive ear wax

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 ear wax 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 (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLYAdults and children over 12 years of age:

consult a doctor Children under 12 years:

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with ear wax 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

1-800-328-5890

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Ear wax removal aid

Uses

INDICATIONS & USAGE SECTION

for occasional use as an aid to soften, loosen, and remove excessive ear wax

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 ear wax 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 ONLYAdults and children over 12 years of age:

consult a doctor Children under 12 years:

  • 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

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 ear wax 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

 Weekdays 8:30-5:00 CST 1-800-328-5890

Package Labeling:Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:62011-0483-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0483HEALTHMART EARWAX REMOVAL KIT EAR WAX DROPS AND BULB (CARBAMIDE PEROXIDE) KIT [MCKESSON CORP VIA STRATEGIC SOURCING SERVICES LLC]4Legacy NDC20250130_4229f02a-bd71-4d27-94d6-ae860bd60d20.zip
62011-0484HEALTHMART EARWAX REMOVAL KIT EAR WAX DROPS AND BULB (CARBAMIDE PEROXIDE) KIT [MCKESSON CORP VIA STRATEGIC SOURCING SERVICES LLC]4Legacy NDC20250130_4229f02a-bd71-4d27-94d6-ae860bd60d20.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0484-1ML - Milliliter62011-0484d5571d7a-103b-4160-ab41-97bc28fd730f12022-10-06
62011-0483-1ML - Milliliter62011-0483e694911a-3c8d-4f1b-b11a-fab933d782aa12022-10-06

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
62011-048462011-0484-1
62011-048362011-0483-1

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
2cdf6775-d49c-59db-e063-6394a90adeba4229f02a-bd71-4d27-94d6-ae860bd60d202025-01-29WarningsExact identifier
spl id: 2cdf6775-d49c-59db-e063-6394a90adeba
spl set id: 4229f02a-bd71-4d27-94d6-ae860bd60d20

Reported adverse events (FAERS/openFDA)#

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