FDA.reportPublic FDA data

Walgreens Ear Wax Remover

Manufacturer
Walgreens Company
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:30

Label at a glance#

ProductWalgreens Ear Wax Remover
Active ingredientCARBAMIDE PEROXIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubb...

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

Ask a Doctor before use if you have

  • eardrainage, discharge, ear pain,irritation
  • rash in the ear,or are dizzy
  • injury or perforation (hole) of the ear drum
  • Recently had ear surgery

Stop Use and ask a Doctor if

OTC - DO NOT USE SECTION

  • you need to use for more than 4 days
  • execessive ear wax remain after use of this product

When using this product

OTC - WHEN USING SECTION

do not use for more than four days
avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
if excessive earwax remains after the use of this product, consult a doctor

Keep 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 FOR USE IN THE EAR ONLY

DOSAGE & ADMINISTRATION SECTION


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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
  • When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

Children under 12 years: consult a doctor.

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

Other information 

OTHER SAFETY INFORMATION

Protect from heat and direct sunlight
product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
Keep cap on bottle when not in use.
Lot No. and EXP date: see label, bottom container or box.

Principal Display Panel Bottle Label 0.5 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Ear Wax Remover  NDC 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Bottle Label 0.5 FL OZPrincipal Display Panel Bottle Label 0.5 FL OZ

Principal Display Panel Carton Label 0.5 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Ear Wax Remover NDC 0363-2068-15

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Carton Label 0.5 FL OZPrincipal Display Panel Carton Label 0.5 FL OZ

Principal Display Panel Kit Label 0.5 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Ear Wax Remover Kit  NDC 0363-2068-25

Ear Wax Removal drops

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel Kit Label 0.5 FL OZPrincipal Display Panel Kit Label 0.5 FL OZ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2068WALGREENS EAR WAX REMOVER (CARBAMIDE PEROXIDE 6.5%) LIQUID [WALGREENS COMPANY]3Current NDC, Legacy NDC20241122_d3b7362b-2826-4b86-bfa3-ef302dc79143.zip

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
0363-20680363-2068-15, 0363-2068-25

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
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TARTARIC ACIDW4888I119HIACT

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
Walgreens Ear Wax RemoverCARBAMIDE PEROXIDE 6.5%Walgreens Companyd3b7362b-2826-4b86-bfa3-ef302dc791432024-11-20WarningsExact identifier
ndc (package): 0363-2068-15
ndc (package): 0363-2068-25
ndc (product): 0363-2068
ndc11 (package): 00363206825
ndc11 (package): 00363206815
spl id: 80b765bf-73fc-48a0-b6dc-441ef9c910f3
spl set id: d3b7362b-2826-4b86-bfa3-ef302dc79143

Reported adverse events (FAERS/openFDA)#

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