Search by Drug Name or NDC
NDC 68093-4503-01 ENT Essentials Ear Wax Remvoer 0.065 g/g Details
ENT Essentials Ear Wax Remvoer 0.065 g/g
ENT Essentials Ear Wax Remvoer is a AURICULAR (OTIC) LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Wisconsin Pharmacal Company. The primary component is CARBAMIDE PEROXIDE.
Product Information
NDC | 68093-4503 |
---|---|
Product ID | 68093-4503_5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | ENT Essentials Ear Wax Remvoer |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Carbamide Peroxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | LIQUID |
Route | AURICULAR (OTIC) |
Active Ingredient Strength | 0.065 |
Active Ingredient Units | g/g |
Substance Name | CARBAMIDE PEROXIDE |
Labeler Name | Wisconsin Pharmacal Company |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part356 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 68093-4503-01 (68093450301)
NDC Package Code | 68093-4503-1 |
---|---|
Billing NDC | 68093450301 |
Package | 1 BOTTLE in 1 CARTON (68093-4503-1) / 22 g in 1 BOTTLE |
Marketing Start Date | 2017-02-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ENT ESSENTIALS EAR WAX REMVOER
carbamide peroxide liquid |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Wisconsin Pharmacal Company (800873986) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Wisconsin Pharmacal Company | 800873986 | manufacture(68093-4503) |
Revised: 11/2017
Document Id: 5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1
Set id: 5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1
Version: 1
Effective Time: 20171108