Ear Wax Remover
Carbamide Peroxide
Proficient Rx Lp
Human Otc Drug
NDC 63187-187Ear Wax Remover also known as Carbamide Peroxide is a human otc drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Ear Wax Remover is 63187-187. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ear Wax Remover drug includes Carbamide Peroxide - 65 mg/mL . The currest status of Ear Wax Remover drug is Active.
Drug Information:
| Drug NDC: | 63187-187 |
| 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: | Ear Wax Remover |
| 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: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | 27 May, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jun, 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: | Proficient Rx LP
|
| 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. |
| 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 |
|---|
| 63187-187-15 | 1 BOTTLE, DISPENSING in 1 CARTON (63187-187-15) / 15 mL in 1 BOTTLE, DISPENSING | 01 Jan, 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:
Uses uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Product Elements:
Ear wax remover carbamide peroxide carbamide peroxide hydrogen peroxide water glycerin propylene glycol citric acid monohydrate sodium lauryl sulfate sodium citrate, unspecified form glyceryl 1-diacetyltartrate 2,3-distearate
Indications and Usage:
Indications and usage uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Warnings:
Warnings warnings ask a doctor before use if you have - ear drainage or discharge - ear pain - irritation or rash in the ear - dizziness - an injury or perforation (hole) of the ear drum - recently had ear surgery stop use and ask a doctor if - you need to use for more than four days - excessive wax remains after use of this product when using this product - avoid contact with the eyes. if accidental contact with the eyes occurs, flush eyes with water and consult your doctor. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away
Dosage and Administration:
Directions directions for use in the ear only unscrew cap from bottle. remove foil safety seal from bottle. affix applicator cap to bottle. 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 cotton in the ear - use twice daily for up to 4 days if needed, or as directed by a doctor - any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber ear syringe. - when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal children under 12 years of age: consult a doctor. other information - avoid exposing the bottle to excessive heat and direct sunlight - keep cap on bottle when not in use - lot no. & exp date: see label, bottom of container or box - retain carton for future reference on full labeling - note: drops foa
Read more...m on contact with ear wax due to release of oxygen. there may be an associated "cracking" sound - note: oversize packaging for ease in reading label information. contains one bottle. - store between 20 degrees to 25 degrees c (68 degrees to 77 degrees f)
Package Label Principal Display Panel:
Principal display panel ndc 63187-187-15 ear wax remover with irrigator earwax removal aid (carbamide peroxide 6.5%) distributed by: major pharmaceuticals 31778 enterprise drive livonia, mi 48150 usa relabeled by: proficient rx lp thousand oaks, ca 91320 63187-187-15