Wax Out Plus
Carbamide Peroxide Drops
Neilmed Pharmaceuticals Inc
Human Otc Drug
NDC 13709-313Wax Out Plus also known as Carbamide Peroxide Drops is a human otc drug labeled by 'Neilmed Pharmaceuticals Inc'. National Drug Code (NDC) number for Wax Out Plus is 13709-313. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Wax Out Plus drug includes Carbamide Peroxide - 65 mg/mL . The currest status of Wax Out Plus drug is Active.
Drug Information:
| Drug NDC: | 13709-313 |
| 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: | Wax Out Plus |
| 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 Drops |
| 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: | 05 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | 0705928604162
|
| 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 |
|---|
| 13709-313-01 | 1 BOTTLE, DROPPER in 1 KIT (13709-313-01) / 15 mL in 1 BOTTLE, DROPPER | 01 Oct, 2019 | 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 removal aid
Product Elements:
Wax out plus carbamide peroxide drops oxyquinoline carbamide peroxide hydrogen peroxide glycerin
Indications and Usage:
Directions for reusable ear cleaners for use in the ear only. make sure to check physical integrity of the tool prior to use. when usingfor teh first time, begin with the coil tool. grasp tool comfortably between thumb, index and middle fingers. direct toward ear. gently advance tool toward the earcanal and spin tool continuously - slowly advancing into the outer portion of canal. rotate in one direction per insertion. for additional extraction, try the bristle, screw or club tools. do not poke or jab into ear. do not forcibly advance. not for deep canal insertion. each person's requirements vary. impacted earwax should be removed by a health care professional. check with your physician. disinfections instructions: clean with soap and warm water followed by immersing eartools in isopropyl rubbing alcohol 70%. use tool when dry. suggested use: intended for ear hygiene: cleaning of debris, itch relief, exfoliation, water extraction and superficial wax around the ear and outer ear canal.
Read more...daily or less frequent use may be beneficial.
Warnings:
Warnings : do not use: if you have had an allergic reactionto carbamide peroxide or other ingredients in teh dropper bottle. if you have ear drainage or discharge, ear pain, ear infections, irritation, rash in the ear, or are dizzy. (please consult a doctor with concerns). if you have an injury or perforation (hole) of the eardrum or after ear surgery or mastoid surgery, unless directed by a doctor. more than a twice a week. for children under 12 years of age. if you have tubes in your ears.
Do Not Use:
Warnings : do not use: if you have had an allergic reactionto carbamide peroxide or other ingredients in teh dropper bottle. if you have ear drainage or discharge, ear pain, ear infections, irritation, rash in the ear, or are dizzy. (please consult a doctor with concerns). if you have an injury or perforation (hole) of the eardrum or after ear surgery or mastoid surgery, unless directed by a doctor. more than a twice a week. for children under 12 years of age. if you have tubes in your ears.
When Using:
When using this product: avoid contact with eyes keep out of reach of children if swallowed, get medical help or contact a poison control center immediately. if accidental contact with eyes occurs, flush eyes with water and consult a doctor. system is designed for a single user to reduce the risk of contamination. do not share with others individuals with meniere's syndrome or those experiencing dizziness, vertigo, impacted earwax or other ear problems should not use this product unless directed by a physician. please do not discard this printed box and any enclosed printed material. the inside final product may not have all the details you require for the ongoing use of the product.
Dosage and Administration:
Directions for dosing to aid with the softening of teh earwax, you may use neilmed clear canal earwax softener in conjunction with the eartools to provide maiximum benefit. remove the cap from the neilmed clear canal earwax softener bottle and squuze a few drops of the solution into the cavity of the cap. dip the tip of the ear tool into the solution so that the tip of the tool is coated with softener solution. follow the directions given for use of the tools. wash the cap with warm water and dry completely before placing back on softener bottle if you wish, you may also place 10 drops of neilmed claer canal earwax softener in teh earcanals as directed prior to use of the eartools. keep ear plugged for 5-10 minutes. now use the tools to remove the softened earwax.
Package Label Principal Display Panel:
Waxout plus - box label waxout plus