NDC 70000-0490 Leader Earwax Removal Kit

Carbamide Peroxide 6.50% Kit

NDC Product Code 70000-0490

NDC Code: 70000-0490

Proprietary Name: Leader Earwax Removal Kit 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 6.50% Kit 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.

NDC Code Structure

  • 70000 - Cardinal Health
    • 70000-0490 - Leader Earwax Removal Kit

NDC 70000-0490-1

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

NDC 70000-0490-2

Package Description: 15 mL in 1 CONTAINER

NDC Product Information

Leader Earwax Removal Kit with NDC 70000-0490 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Earwax Removal Kit is carbamide peroxide 6.50% kit. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Cardinal Health

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.

Leader Earwax Removal Kit 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 6.5 g/100mL

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.

  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • WATER (UNII: 059QF0KO0R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM STANNATE (UNII: NJ7C1V83KG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Cardinal Health
Labeler Code: 70000
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: 05-06-2019 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: 12-31-2020 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.

Leader Earwax Removal Kit Product Label Images

Leader Earwax Removal Kit 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

Otc - Active Ingredient

Carbamide Peroxide 6.5% non USP**pH differs from USP specifications

Otc - Purpose

Earwax removal aid

Indications & Usage

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

Warnings

Ask a doctor before use if you have:ear drainage or dischargeear pain, irritation, or rash in earrecently had ear surgerydizzinessan injury or perforation of the eardrum

Inactive Ingredient

Citric acidFlavorGlyrcerinPropylene glycolSodium Lauroyl SarcosinateSodium StannatePurified water

Dosage & Administration

  • ​tilt head sidewayspalce 5 to 10 drops into eartip of applicator should not enter ear canalkeep drops in ear for several minutes by keeping head tilted or placing cotton in the earuse twice daily for up to four days if needed, or as directed by a doctorany wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe

Otc - Keep Out Of Reach Of Children

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

* Please review the disclaimer below.

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