Walgreens Ear Wax Remover
Carbamide Peroxide 6.5%
Walgreens Company
Human Otc Drug
NDC 0363-2068Walgreens Ear Wax Remover also known as Carbamide Peroxide 6.5% is a human otc drug labeled by 'Walgreens Company'. National Drug Code (NDC) number for Walgreens Ear Wax Remover is 0363-2068. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Walgreens Ear Wax Remover drug includes Carbamide Peroxide - .065 mg/mL . The currest status of Walgreens Ear Wax Remover drug is Active.
Drug Information:
| Drug NDC: | 0363-2068 |
| 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: | Walgreens 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 6.5% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens Company |
| 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: | 28 Apr, 2014 |
| 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: | Walgreens Company
|
| 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. |
| 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 |
|---|
| 0363-2068-15 | 1 BOTTLE, DROPPER in 1 CARTON (0363-2068-15) / 15 mL in 1 BOTTLE, DROPPER | 28 Apr, 2014 | N/A | No |
| 0363-2068-25 | 1 BOTTLE, DROPPER in 1 KIT (0363-2068-25) / 15 mL in 1 BOTTLE, DROPPER | 28 Apr, 2014 | 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 ear wax removal aid
Product Elements:
Walgreens ear wax remover carbamide peroxide 6.5% carbamide peroxide hydrogen peroxide glycerin anhydrous citric acid propylene glycol sodium citrate sodium lauryl sulfate tartaric acid
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 eardrainage, discharge, ear pain,irritation rash in the ear,or are dizzy injury or perforation (hole) of the ear drum recently had ear surgery
Do Not Use:
Warnings ask a doctor before use if you have eardrainage, discharge, ear pain,irritation rash in the ear,or are dizzy injury or perforation (hole) of the ear drum recently had ear surgery
When Using:
When using this product do not use for more than four days avoid contact with the eyes. if accidental contact with the eyes occurs, flush eyes with water and consult a doctor if excessive earwax remains after the use of this product, consult a doctor
Dosage and Administration:
Directions for use in the ear only 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb 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: consult a doctor.
Package Label Principal Display Panel:
Principal display panel bottle label 0.5 fl oz walgreens ear wax remover ndc 0363-2068-15 ear wax removal drops carbamide peroxide 6.5% 0.5 fl oz (15ml) principal display panel bottle label 0.5 fl oz
Principal display panel carton label 0.5 fl oz walgreens ear wax remover ndc 0363-2068-15 ear wax removal drops carbamide peroxide 6.5% 0.5 fl oz (15ml) principal display panel carton label 0.5 fl oz
Principal display panel kit label 0.5 fl oz walgreens ear wax remover kit ndc 0363-2068-25 ear wax removal drops carbamide peroxide 6.5% 0.5 fl oz (15ml) principal display panel kit label 0.5 fl oz