NDC 52412-600 Earwax Removal Drops

Carbamide Peroxide 6.5%

NDC Product Code 52412-600

NDC CODE: 52412-600

Proprietary Name: Earwax Removal Drops 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 6.5% 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

  • 52412 - Randob Labs, Ltd.

NDC 52412-600-05

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Earwax Removal Drops with NDC 52412-600 is a a human over the counter drug product labeled by Randob Labs, Ltd.. The generic name of Earwax Removal Drops is carbamide peroxide 6.5%. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Randob Labs, Ltd.

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.

Earwax Removal Drops 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.

  • CARBAMIDE PEROXIDE .065 mg/mL

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.

  • CHAMOMILE (UNII: FGL3685T2X)
  • OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • 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.
  • 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: Randob Labs, Ltd.
Labeler Code: 52412
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: 07-03-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Earwax Removal Drops Product Label Images

Earwax Removal Drops 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

Dosage & Administration

FOR USE IN THE EAR ONLYAdults & Children over 12 yrs of age: Tilt head to the side and place 5-10 drops into ear.Dropper tip of removal drops 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.Safely scoop out wax with removal tool.Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.Children under 12 yrs of age:Consult a doctor.

Indications & Usage

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

Otc - Purpose

Earwax Removal Aid

Otc - Active Ingredient

Carbamide Peroxide 6.5%

Inactive Ingredient

Aloe Barbadensis Leaf ExtractChamomilla Recutita (Matricaria) Flower ExtractGlycerinMineral OilOxyquinoline Sulfate

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.

Otc - When Using

When using this product avoid contact with eyes.

Otc - Stop Use

Stop use and ask a doctor if:you need to use more than four daysexcessive earwax remains after use of this product

Other Safety Information

Other InformationDo not use if neck wrap imprinted safety seal is broken or missingDo not store above 25 degrees C, 77 degrees FStore bottle in outer cartonKeep cap on bottle when not in useProduct foams on contacy with earwax due to release of oxygen

Warnings

WarningsAsk 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

* Please review the disclaimer below.