Earwax Removal Drops
Carbamide Peroxide 6.5%
Humco Holding Group, Inc
Human Otc Drug
NDC 0395-9133Earwax Removal Drops also known as Carbamide Peroxide 6.5% is a human otc drug labeled by 'Humco Holding Group, Inc'. National Drug Code (NDC) number for Earwax Removal Drops is 0395-9133. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Earwax Removal Drops drug includes Carbamide Peroxide - .065 mg/mL . The currest status of Earwax Removal Drops drug is Active.
Drug Information:
| Drug NDC: | 0395-9133 |
| 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: | Earwax Removal 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: | Humco Holding Group, 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: | 04 Jun, 2019 |
| 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: | 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: | Humco Holding Group, Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0096295137040
|
| 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 |
|---|
| 0395-9133-45 | 1 BOTTLE, DROPPER in 1 CARTON (0395-9133-45) / 15 mL in 1 BOTTLE, DROPPER | 04 Jun, 2019 | N/A | No |
| 0395-9133-90 | 1 CONTAINER in 1 CARTON (0395-9133-90) / 15 mL in 1 CONTAINER | 04 Jun, 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:
Earwax removal aid.
Product Elements:
Earwax removal drops carbamide peroxide 6.5% water sodium stannate sodium lauroyl sarcosinate anhydrous citric acid glycerin propylene glycol carbamide peroxide hydrogen peroxide
Indications and Usage:
For occasional use as an aid to soften, loosen and remove excessive earwax.
Warnings:
For external use only. ask a doctor before use if you have: ear drainage or discharge ear pain, irritation, or rash in the ear recently had ear surgery dizziness an injury or perforation (hole) of the eadrum
Dosage and Administration:
Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.
Package Label Principal Display Panel:
Cvs label cvswax.jpg carton
Leader label leader2022 ldrearwax45.jpg ldrewawax90.jpg
Rite aid label rite aid earwax kit 2022 raearwax45.jpg raearwax90.jpg
Major label majorearwax90.jpg