Neilmed Clear Canal Earwax Removal Kit
Carbamide Peroxide
Neilmed Pharmaceuticals Inc
Human Otc Drug
NDC 13709-314Neilmed Clear Canal Earwax Removal Kit also known as Carbamide Peroxide is a human otc drug labeled by 'Neilmed Pharmaceuticals Inc'. National Drug Code (NDC) number for Neilmed Clear Canal Earwax Removal Kit is 13709-314. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Neilmed Clear Canal Earwax Removal Kit drug includes Carbamide Peroxide - 65 mg/mL . The currest status of Neilmed Clear Canal Earwax Removal Kit drug is Active.
Drug Information:
| Drug NDC: | 13709-314 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Neilmed Clear Canal Earwax Removal Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Carbamide Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Neilmed Pharmaceuticals Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CARBAMIDE PEROXIDE - 65 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | AURICULAR (OTIC)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 25 Dec, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part344 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | NEILMED PHARMACEUTICALS INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 702050
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0705928602755
|
| UPC stands for Universal Product Code. |
| UNII: | 31PZ2VAU81
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 13709-314-01 | 1 BOTTLE, DROPPER in 1 KIT (13709-314-01) / 15 mL in 1 BOTTLE, DROPPER | 25 Dec, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose earwax softener
Product Elements:
Neilmed clear canal earwax removal kit carbamide peroxide carbamide peroxide hydrogen peroxide glycerin oxyquinoline
Indications and Usage:
Uses for occasional use as an aid to soften, loosen, and remove excessive earwax.
Directions for use in the ear only adults and children over 12 years of age: tilt head sideways place 10 drops into each ear tip of the applicator should not enter ear canal keep drops in the ears for ten minutes by keeping your head tilted or using earplugs rinse ears after treatment by gently flusing each ear with neilmed®clearcanal® spray or bulb syringe use up to twice per week, or as recommended by your physician.
Warnings:
! warnings avoid using the product and ask a doctor before use if you have : ear pain, drainage or discharge impacted earwax ear infection, irritation or rash in the ear. meniere's syndrome, dizziness, or vertigo an injury or perforation (hole) of the eardrum tubes in the ears has recent ear/mastoid surgery had an allergic reaction to carbamide peroxide or other ingredients in this product in the past. heart disease, high blood pressure, thyroid disease or diabetes to prevent contamination, do not share this product with others.
When Using:
When using this product: avoid contact with the eyes. if accidental contact occurs, flush eyes with water and consult a doctor.
Dosage and Administration:
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.
Stop Use:
Stop use and ask a doctor if: excessive earwax remains after use of this product you wish to use this product more than twice per week
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