ENT Essentials Ear Wax Remvoer

Manufacturer
Wisconsin Pharmacal Company
Effective date
2017-11-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:06

Label at a glance#

ProductENT Essentials Ear Wax Remvoer
Active ingredientCARBAMIDE PEROXIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Carbamide Peroxide 6.5%

OTC - PURPOSE SECTION

Purpose

Earwax removal aid

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Aska doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation or rash in the ear
  • dizziness
  • an injury or perforation (hole) of the eardrum
  • recently had ear surgery

OTC - WHEN USING SECTION

When using this product avoid contact wtih the eyes

OTC - STOP USE SECTION

Stop use and aks a doctor if

  • you need to use for more than four days
  • excessive earwax remains after use of this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

D irections

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

tilt head sideways
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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.

Children under 12 years: consult a doctor.

OTHER SAFETY INFORMATION

Other informaiton

  • store bottle in teh outer carton
  • product foams on contact with earwax due to the release of oxygen. Theremay be an associated "crackling" sound
  • keep cap on bottle when not in use

INACTIVE INGREDIENT SECTION

Inactive ingredients

Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid

OTC - QUESTIONS SECTION

Questions or comments? 1-800-635-3696

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label and CartonLabel and Carton

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68093-4503-1ENT Essentials Ear Wax Remvoer1 in 1 CARTONLIQUID11
68093-4503-1ENT Essentials Ear Wax Remvoer22 g in 1 BOTTLELIQUID221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68093-4503ENT ESSENTIALS EAR WAX REMVOER (CARBAMIDE PEROXIDE) LIQUID [WISCONSIN PHARMACAL COMPANY]1Current NDC, Legacy NDC, 2 package rows20171128_5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68093-450368093-4503-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENT Essentials Ear Wax RemvoerCARBAMIDE PEROXIDEWisconsin Pharmacal Company5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b12017-11-08WarningsExact identifier
ndc (package): 68093-4503-1
ndc (product): 68093-4503
ndc11 (package): 68093450301
spl id: 5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1
spl set id: 5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1

Reported adverse events (FAERS/openFDA)#

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