NDC 11673-793 Ear Wax Removal Aid Drops

Carbamide Peroxide

NDC Product Code 11673-793

NDC Code: 11673-793

Proprietary Name: Ear Wax Removal Aid Drops Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 11673 - Target Corporation
    • 11673-793 - Ear Wax Removal Aid Drops

NDC 11673-793-15

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

NDC Product Information

Ear Wax Removal Aid Drops with NDC 11673-793 is a a human over the counter drug product labeled by Target Corporation. The generic name of Ear Wax Removal Aid Drops is carbamide peroxide. The product's dosage form is liquid and is administered via auricular (otic) form.

Labeler Name: Target Corporation

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 Additional informationCallout TooltipWhat 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.


Ear Wax Removal Aid Drops Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

  • ADIPIC ACID (UNII: 76A0JE0FKJ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Target Corporation
Labeler Code: 11673
FDA Application Number: part344 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-05-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Ear Wax Removal Aid Drops Product Label Images

Ear Wax Removal Aid 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

Other

Drug Facts

Active Ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

For occasional use as an aid to soften, loosen and remove excessive ear wax

Ask A 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

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • •you need to use for more than four days •excessive ear wax remains after use this product

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • FOR USE IN THE EAR ONLY. •Adults and children over 12 years of age: •tilt head sideways •place 5 to 10 drops into 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 the ear. •Use twice daily for up to 4 days if needed, or as directed by a doctor. •Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.Children under 12 years of age: consult a doctor.

Other Information

  • •Store at room temperature •Avoid exposing bottle to excessive heat and direct sunlight •Store bottle in the outer carton •Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound. •Keep cap on bottle when not in use

Inactive Ingredients

Adipic acid, glycerin, polysorbate 80.

* Please review the disclaimer below.

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