NDC 13710-230 Clear Canal Earwax Softener Drops

Clear Canal Earwax Softener Drops

NDC Product Code 13710-230

NDC Code: 13710-230

Proprietary Name: Clear Canal Earwax Softener 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: Clear Canal Earwax Softener Drops 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
  • 13710 - Neilmed Pharmaceuticals, Inc.
    • 13710-230 - Clear Canal Earwax Softener Drops

NDC 13710-230-15

Package Description: 15 mL in 1 BOX

NDC Product Information

Clear Canal Earwax Softener Drops with NDC 13710-230 is a a human over the counter drug product labeled by Neilmed Pharmaceuticals, Inc.. The generic name of Clear Canal Earwax Softener Drops is clear canal earwax softener drops. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

Labeler Name: Neilmed Pharmaceuticals, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.


Clear Canal Earwax Softener 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 6.5 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.

  • GLYCERIN (UNII: PDC6A3C0OX)

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: Neilmed Pharmaceuticals, Inc.
Labeler Code: 13710
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-16-2019 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.

Clear Canal Earwax Softener Drops Product Label Images

Clear Canal Earwax Softener 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

Warnings

WarningsDo Not Use and consult a doctor if you have excessive drainage or discharge ear pain, irritation, or rash in the ear or feel dizzy. Do not use if you have an perforation (hole) of the eardrum or after ear surger unless directed by a doctor. Do not use for more than four days. If excessive earwax remains after use of this products, consult a doctor.Image Reference: Clear Canal Earwax Softner Drop Product Label.jpgClear Canal Earwax Softner Drops Outer box carton.jpg

Dosage And Administration

For use in the ear only. Adult and Children over 12 years of age: Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in the ear for 3 to 5 minutes by keeping your head tilted or use earplugs. Rinse ear after treatment by gently flushing the ear with NeilMed ClearCanal (supplied in a canister with a special ear rinse adapter). Use twice daily for up to four days if needed or as directed by a doctor. Children under 12 years of age: Consult a doctor.

Otc - Keep Out Of Reach Of Children

Keep this & all drugs out of the reach of children. In case of accident ingestion, seek professional assistance or contact a poison control center.

Indication And Usage

For use in the ear only. Adult and Children over 12 years of age: Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in the ear for 3 to 5 minutes by keeping your head tilted or use earplugs. Rinse ear after treatment by gently flushing the ear with NeilMed ClearCanal (supplied in a canister with a special ear rinse adapter). Use twice daily for up to four days if needed or as directed by a doctor. Children under 12 years of age: Consult a doctor.

Otc Purpose Section

For use in the ear only. Adult and Children over 12 years of age: Tilt head sideways and place 5-10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in the ear for 3 to 5 minutes by keeping your head tilted or use earplugs. Rinse ear after treatment by gently flushing the ear with NeilMed ClearCanal (supplied in a canister with a special ear rinse adapter). Use twice daily for up to four days if needed or as directed by a doctor. Children under 12 years of age: Consult a doctor.

Otc Active Ingredient Section

Carbamide Peroxide

Inactive Ingredient Section

Glycerine

* Please review the disclaimer below.

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