Ear Wax Removal Aid Drops
Carbamide Peroxide
Pharmacy Value Alliance, Llc
Human Otc Drug
NDC 68016-793Ear Wax Removal Aid Drops also known as Carbamide Peroxide is a human otc drug labeled by 'Pharmacy Value Alliance, Llc'. National Drug Code (NDC) number for Ear Wax Removal Aid Drops is 68016-793. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ear Wax Removal Aid Drops drug includes Carbamide Peroxide - .065 mg/mL . The currest status of Ear Wax Removal Aid Drops drug is Active.
Drug Information:
| Drug NDC: | 68016-793 |
| 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 Removal Aid 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: | Pharmacy Value Alliance, Llc |
| 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 - .065 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: | 18 Apr, 2019 |
| 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: | PHARMACY VALUE ALLIANCE, LLC
|
| 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: | 0840986035500
|
| 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 |
|---|
| 68016-793-15 | 1 BOTTLE, DROPPER in 1 CARTON (68016-793-15) / 15 mL in 1 BOTTLE, DROPPER | 18 Apr, 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:
Ear wax removal aid drops carbamide peroxide carbamide peroxide hydrogen peroxide adipic acid glycerin polysorbate 80
Indications and Usage:
Uses for occasional use as an aid to soften, loosen and remove excessive ear wax
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 eardrum ? recently had ear surgery when using this product avoid contact with the eyes stop use and ask a doctor if ? you need to use for more than four days ? excessive ear wax remains after use this product keep out of reach of children. if swallowed, get medical help or contact a poison control center right away at (1-800-222-1222).
When Using:
When using this product avoid contact with the eyes
Dosage and Administration:
Directions for use in the ear only. ? adults and children over 12 years of age: ? tilt head sideways ? place 5 to 10 drops into ear canal. ? 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 four 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 bulb ear syringe. children under 12 years of age: consult a doctor.
Stop Use:
Stop use and ask a doctor if ? you need to use for more than four days ? excessive ear wax remains after use this product
Package Label Principal Display Panel:
Principal display panel premier value® ndc 68016-793-15 *compare to the active ingredient in debrox ® drops ear wax removal aid drops kit carbamide peroxide 6.5% ear wax removal aid safe & gentle microfoam cleansing action easy to use instructions net wt 0.5 fl oz (15 ml) this kit include soft rubber bulb ear syringe and drops tamper evident: do not use if outer carton is open or torn important: keep the carton for future reference on full labeling. distributed by: pharmacy value alliance, llc 407 east lancaster avenue, wayne, pa 19087 *this product is not manufactured or distributed by medtech products inc. the distributor of debrox ® drops. eaxr wax removal aid drops carbamide peroxide
Further Questions:
Questions or comments? 1-866-467-2748