FDA.reportPublic FDA data

Ear Wax Removal Drops

Manufacturer
Kinray | Sheffield Pharmaceuticals LLC
Effective date
2017-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:23

Label at a glance#

ProductEar Wax Removal Drops Preferred Plus Pharmacy
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 ...

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

Do not use if you have 

  • eardrainage, discharge, ear pain,irritation
  • rashin the ear,or are dizzy
  • injuryor perforation (hole) of the ear drum or after ear surgery

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 
  • 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 0.5 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Preferred Plus Pharmacy

Ear Wax Removal drops 

Carbamide Peroxide 6.5%

0.5 FL OZ (15ml)

Principal Display Panel - Carton label 0.5 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Carton label 0.5 FL OZPrincipal Display Panel - Carton label 0.5 FL OZ

Preferred  Plus Pharmacy

Ear wax Remover Drops 

Carbamide Peroxide 6.5%

Ear wax removal aid 

0.5 FL OZ ( 15ml)

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
61715-17161715-171-74

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
0b043fc1-540a-45e1-ad54-20f8d19ce29414ec35fa-d211-4e5c-b5a7-3e358084db972025-05-16WarningsExact identifier
spl set id: 14ec35fa-d211-4e5c-b5a7-3e358084db97

Reported adverse events (FAERS/openFDA)#

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