Clearcanal Ear Wax Softerner Drops
Carbamide Peroxide
Neilmed Pharmaceuticals, Inc.
Human Otc Drug
NDC 13709-230Clearcanal Ear Wax Softerner Drops also known as Carbamide Peroxide is a human otc drug labeled by 'Neilmed Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Clearcanal Ear Wax Softerner Drops is 13709-230. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Clearcanal Ear Wax Softerner Drops drug includes Carbamide Peroxide - 65 mg/mL . The currest status of Clearcanal Ear Wax Softerner Drops drug is Active.
Drug Information:
| Drug NDC: | 13709-230 |
| 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: | Clearcanal Ear Wax Softerner Drops |
| 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: | 24 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| 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
1245627
|
| 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. |
| 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 |
|---|
| 13709-230-01 | 1 BOTTLE, DROPPER in 1 BOX (13709-230-01) / 15 mL in 1 BOTTLE, DROPPER | 02 Jan, 2012 | N/A | No |
| 13709-230-10 | 1 BOTTLE in 1 KIT (13709-230-10) / 15 mL in 1 BOTTLE | 24 Aug, 2012 | 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:
Softens ear wax. ear wax removal drops
Product Elements:
Clearcanal ear wax softerner drops carbamide peroxide glycerin oxyquinoline carbamide peroxide hydrogen peroxide
Indications and Usage:
Ear wax removal drops directions step 1 ear wax removal drops directions: for use in the ear only. adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. tip of applicator should not enter ear canal. keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear. use twice daily for upto 4 days if needed or as directed by a doctor. any wax remaining after treatment may be removed by gently flushing the ear with neilmed clearcanal rinsing system with special ear rinse adapter. children under 12 years of age: consult a doctor.
Warnings:
Warnings: do not use: if you have had an allergic reaction to carbamide peroxide. if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor if you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor for more than four consecutive days when using this product: void contact with the eyes stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.
Do Not Use:
Warnings: do not use: if you have had an allergic reaction to carbamide peroxide. if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor if you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor for more than four consecutive days when using this product: void contact with the eyes stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days.
When Using:
When using this product: * avoid contact with the eyes
Dosage and Administration:
Place 5 to 10 drops of 6.5% carbamide peroxide solution into e
Stop Use:
Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days
Description:
Ear wax removal complete system ear wax is an important part of your body's system for keeping dirt, bacteria and other things from causing hearing problems. when rinsing is necessary, this cleaning system helps to soften, loosen and remove the excessive ear wax. the system consists of kit with 1 bottle carbamide peroxide solution 15ml and 1 can sterile saline spray 177ml (or 125ml).
Package Label Principal Display Panel:
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Clearcanal earwax removal kit_product label neilmed clearcanal earwax removal kit