Ear Drops
Carbamide Peroxide 6.5%
Bionpharma Inc.
Human Otc Drug
NDC 69452-377Ear Drops also known as Carbamide Peroxide 6.5% is a human otc drug labeled by 'Bionpharma Inc.'. National Drug Code (NDC) number for Ear Drops is 69452-377. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ear Drops drug includes Carbamide Peroxide - .065 mg/mL . The currest status of Ear Drops drug is Active.
Drug Information:
| Drug NDC: | 69452-377 |
| 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 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 6.5% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bionpharma Inc. |
| 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: | 15 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | M014 |
| 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, 2024 |
| 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: | Bionpharma 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: | 0369452377956
|
| 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 |
|---|
| 69452-377-75 | 1 BOTTLE, DROPPER in 1 CARTON (69452-377-75) / 15 mL in 1 BOTTLE, DROPPER | 15 Sep, 2022 | N/A | No |
| 69452-377-95 | 2 BOTTLE, DROPPER in 1 CARTON (69452-377-95) / 15 mL in 1 BOTTLE, DROPPER | 15 Sep, 2022 | 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:
Purposes earwax removal aid
Product Elements:
Ear drops carbamide peroxide 6.5% anhydrous citric acid sodium stannate sodium lauroyl sarcosinate propylene glycol water glycerin carbamide peroxide hydrogen peroxide
Indications and Usage:
Uses for occasional use as an aid to soften, loosen and remove excessive earwax
Warnings:
Warnings do not use 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 ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. if excessive earwax remains after use of this product, consult a doctor. when using this product avoid contact with eyes stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product keep this and all drugs out of the reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use 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 ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. if excessive earwax remains after use of this product, consult a doctor. when using this product avoid contact with eyes stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product keep this and all drugs out of the reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product
Dosage and Administration:
Directions for use in the ear only remove any earing aids before use adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear. tip of applicator should not enter into the ear canal keep drops in ear for several minutes by keeping head tilted sideways 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 bulb ear syringe. children under 12 yrs of age: consult a physician.
Package Label Principal Display Panel:
Carton labeling *compare to the active ingredient in debrox® ear drops twin pack a+health ear drops carbamide peroxide 6.5% earwax removal aid safe, gentle, non-irritating easily cleanses ear with microfoam action 1 fl oz (30ml) two bottles 0.5 fl oz (15 ml) each carton