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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68093-4503-1 | ENT Essentials Ear Wax Remvoer | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 68093-4503-1 | ENT Essentials Ear Wax Remvoer | 22 g in 1 BOTTLE | LIQUID | 22 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68093-4503 | ENT ESSENTIALS EAR WAX REMVOER (CARBAMIDE PEROXIDE) LIQUID [WISCONSIN PHARMACAL COMPANY] | 1 | Current NDC, Legacy NDC, 2 package rows | 20171128_5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1.zip |
Products#
Every source-derived product name is available through these pages.
- ENT Essentials Ear Wax Remvoer
- Carbamide Peroxide
- TARTARIC ACID
- GLYCERIN
- PROPYLENE GLYCOL
- SODIUM CITRATE
- HYDROGEN PEROXIDE
- POLYSORBATE 20
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68093-4503 | 68093-4503-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TARTARIC ACID | W4888I119H | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| CARBAMIDE PEROXIDE | 31PZ2VAU81 | ACTIB |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ENT Essentials Ear Wax Remvoer | CARBAMIDE PEROXIDE | Wisconsin Pharmacal Company | 5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1 | 2017-11-08 | Warnings | 68093-4503-1 68093-4503 68093450301 5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1 5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
