NDC 13709-314 Neilmed Clear Canal Earwax Removal Kit

Carbamide Peroxide

NDC Product Code 13709-314

NDC CODE: 13709-314

Proprietary Name: Neilmed Clear Canal 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 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

  • 13709 - Neilmed Pharmaceuticals Inc
    • 13709-314 - Neilmed Clear Canal Earwax Removal Kit

NDC 13709-314-01

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

NDC Product Information

Neilmed Clear Canal Earwax Removal Kit with NDC 13709-314 is a a human over the counter drug product labeled by Neilmed Pharmaceuticals Inc. The generic name of Neilmed Clear Canal Earwax Removal Kit is carbamide peroxide. The product's dosage form is solution/ drops 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: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Neilmed Clear Canal 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.


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • OXYQUINOLINE (UNII: 5UTX5635HP)

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: Neilmed Pharmaceuticals Inc
Labeler Code: 13709
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: 12-25-2021 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: 12-31-2022 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.

Neilmed Clear Canal 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

Drug Facts

Active Ingredients Carbamide Peroxide 6.5%

Purpose

Earwax Softener

Uses

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

! Warnings

  • Avoid using the product and ask a doctor before use if you have :Ear pain, drainage or dischargeImpacted earwaxEar infection, irritation or rash in the ear.Meniere's Syndrome, dizziness, or vertigoAn injury or perforation (hole) of the eardrumTubes in the earsHas recent ear/mastoid surgeryHad an allergic reaction to carbamide peroxide or other ingredients in this product in the past.Heart disease, high blood pressure, thyroid disease or diabetesTo prevent contamination, do not share this product with others.

When Using This Product:

Avoid contact with the eyes. If accidental contact occurs, flush eyes with water and consult a doctor.

Stop Use And Ask A Doctor If:

  • Excessive earwax remains after use of this productYou wish to use this product more than twice per week

Keep This And All Drugs Out Of The Reach Of Children

Children under 12 years should not use this product.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 sidewaysPlace 10 drops into each earTip of the applicator should not enter ear canalKeep drops in the ears for ten minutes by keeping your head tilted or using earplugsRinse ears after treatment by gently flusing each ear with NeilMed®ClearCanal® spray or bulb syringeUse up to twice per week, or as recommended by your physician.

Other Information:

  • Store product in the outer carton, and do not discard carton or enclosed printed materials.Product will foam on contact with earwax due to release of oxygen; there may be an associated crackling sound.Keep cap on bottle when not in use.Contents in canister are under pressure; do not puncture or incinerate Recommended storage conditions:Store between 59°F and 86°F (15°C to 30°C). Product can temporarily be exposed to temperatures ranging from 41ºF to 131ºF (5ºC to 55ºC) during transportation.Store out of sunlight, away from heat sources and avoid freezing

Inactive Ingredients

Glycerin, Oxyquinoline

Ingredients For Clearcanal® Saline Spray :

  • USP Grade Water, USP Sodium Chloride (9mg/ml), USP Sodium Bicarbonate (0.4mg to 1.0mg/ml) to neutralize pH.Benzalkonium Chloride is added as a preservative

Contents :

1 can saline spray 75ml (2.53 fl oz), 1 bottle of ear drops 15ml (0.5 fl oz), 1 drainage collection cup, 2 ear plugs, 1 waxout tool and 1 soft silicone ear syringe. Colors of parts may vary.

Directions:

This product is intended for use on adults and children over 12 years of age. Consult your physician for use on children under 12.Tilt head sideways and place 10 drops of ClearCanal Carbamide peroxide into each ear canal by squeezing the plastic dropper bottle provided with this system. The tip of bottle should not enter ear canal.Keep drops in ear for 10 minutes by head tilted or placing enclosed ear plugs in ears. It is normal to feel warmth in ear due to carbamide peroxide. Remove ear plugs. Attach the special drainage collection cup to the canister to avoid the rinse solution dripping out of your ear. Flush ears with the NeilMed ClearCanal specially designed actuator nozzle for 10 seconds or as desired to achieve adequate flushing. Gently tilt head side to side to drain out residual liquid and dry ears with a clean dry towel wrapped on a finger.

* Please review the disclaimer below.