NDC 68229-101 Clinere Ear Wax Remover

Carbamide Peroxide

NDC Product Code 68229-101

NDC CODE: 68229-101

Proprietary Name: Clinere Ear Wax Remover What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Carbamide Peroxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat earwax buildup. It helps to soften, loosen, and remove the earwax. Too much earwax can block the ear canal and reduce hearing. This medication releases oxygen and starts to foam when it comes in contact with the skin. The foaming helps break up and remove the earwax. Consult your doctor before using this product in children younger than 12 years.

NDC Code Structure

NDC 68229-101-03

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE (68229-101-01)

NDC 68229-101-04

Package Description: 2 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE (68229-101-01)

NDC Product Information

Clinere Ear Wax Remover with NDC 68229-101 is a a human over the counter drug product labeled by Quest Products. The generic name of Clinere Ear Wax Remover is carbamide peroxide. The product's dosage form is liquid and is administered via auricular (otic) form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 702050.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Clinere Ear Wax Remover Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Auricular (otic) - Administration to or by way of the ear.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Quest Products
Labeler Code: 68229
FDA Application Number: part344 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-09-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2023 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Clinere Ear Wax Remover Product Label Images

Clinere Ear Wax Remover Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Carbamide Peroxide 6.5%

Purpose

Earwax Removal Aid

Uses

For occassional use as an aid to soften, loosen and remove excess earwax.

Warnings

For external use only

Otc - Do Not Use

Do not useThis product for more than 4 days

Ask A Doctor Before Use If You Have

  • Ear drainage or dischargeear painirritation or rash in the eardizzinessan injury or perforation (hole) of the eardrumrecently had ear surgery

When Using This Product

Avoid contact with eyes. If accidental contact occurs, flush eyes with warm water.

Otc - Stop Use

  • Stop use and ask a Doctor ifyou need to use for more than four daysexcessive earwax remains after use of this product

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5-10 drops into each ear canal.
  • Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear. Use twice daily for up to four days if needed, or as directed by doctor.Any wax remaining in the ear may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe, or by use of the included Clinere® ear cleaning tool. (See separate directions)Children under 12 years of age: Consult a doctor.

Other Information

  • Store at 15° - 30°C (59° - 86°F)Avoid excessive heat.Keep cap on bottle when not in use

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Trisodium Citrate Dihydrate, Water

* Please review the disclaimer below.