Ear Wax Removal Drops

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:57:13

Label at a glance#

ProductEar Wax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure10 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%

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 - Carton label 0.5 FL OZ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-976-152024-08-14C16284748780-1f386c649-c5e9-0266-e053-dadaa90a7c1aDrug Facts
66267-976-152023-01-30C16284748780-1f386c649-c5e9-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-976-15ML - Milliliter66267-976cb0abd19-38d8-4971-a5d0-81a92ff1c12a12019-06-19
57896-339-05ML - Milliliter57896-33960f9d315-f236-4cbe-ba42-4d7e2bd5bcca12018-01-12

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
66267-97666267-976-15
57896-339

Ingredients#

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

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

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%GeriCare Pharmaceutical Corp239702af-cf93-43ee-b1af-8e53642395c12025-12-09WarningsExact identifier
ndc (product): 57896-339
1fa7e320-3303-5a51-e063-6294a90a9edf88403f3a-4de0-082c-e053-2a95a90a7cba2024-08-14WarningsExact identifier
spl set id: 88403f3a-4de0-082c-e053-2a95a90a7cba

Reported adverse events (FAERS/openFDA)#

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