FDA.reportPublic FDA data

Ear Wax Removal Drops

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2022-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:22

Label at a glance#

ProductEar Wax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure11 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

Earwax 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.

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.

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

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

Principal Display Panel -Bottle Label 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield       

Earwax Removal Aid Drops 

Carbamide Peroxide 6.5%

NET 0.5 FLOZ (15 ml )

543480-Sheffield-Ear-Wax-Drops_BOX543480-Sheffield-Ear-Wax-Drops_BOX

7004681B-Sheffield-Ear-Drops-LBL7004681B-Sheffield-Ear-Drops-LBL

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-143-51Ear Wax Removal Drops1 in 1 CARTONSOLUTION/ DROPS11
11527-143-51Ear Wax Removal Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-143EAR WAX REMOVAL DROPS (CARBAMIDE PEROXIDE - 6.5%) SOLUTION/ DROPS [SHEFFIELD PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240628_aad7e2cd-cb28-423c-a441-eabe6516d40f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-143-51ML - Milliliter11527-1438306e8f7-af13-4b97-9fef-770f1180633f12024-11-05

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
11527-14311527-143-51

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
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
ndc (package): 11527-143-51
ndc (product): 11527-143
ndc11 (package): 11527014351
spl id: 184c7110-33c6-4b58-bc79-451870131f3a
spl set id: aad7e2cd-cb28-423c-a441-eabe6516d40f

Reported adverse events (FAERS/openFDA)#

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