Modesa Acne Treatment
Benzoyl Peroxide
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Human Otc Drug
NDC 55621-017Modesa Acne Treatment also known as Benzoyl Peroxide is a human otc drug labeled by 'Zhejiang Jingwei Pharmaceutic Al Co., Ltd.'. National Drug Code (NDC) number for Modesa Acne Treatment is 55621-017. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Modesa Acne Treatment drug includes Benzoyl Peroxide - 10 g/100g . The currest status of Modesa Acne Treatment drug is Active.
Drug Information:
| Drug NDC: | 55621-017 |
| 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: | Modesa Acne Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Modesa |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Acne Treatment |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Zhejiang Jingwei Pharmaceutic Al Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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: | BENZOYL PEROXIDE - 10 g/100g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 20 Aug, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | part333D |
| 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: | Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106315
|
| 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. |
| UNII: | W9WZN9A0GM
|
| 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 |
|---|
| 55621-017-01 | 1 TUBE in 1 CARTON (55621-017-01) / 28 g in 1 TUBE | 20 Aug, 2017 | 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 acne medication
Product Elements:
Modesa acne treatment benzoyl peroxide benzoyl peroxide benzoyl peroxide aluminum hydroxide bentonite carbomer 940 diglycerin monostearate methylparaben polyethylene glycol 600 potassium hydroxide propylene glycol propylparaben water
Indications and Usage:
Uses for the treatment and prevention of acne pimples
Warnings:
Warnings â¢for external use only do not use â¢if you have sensitive skin or are sensitive to benzoyl peroxide when using this product â¢avoid contact with eyes, lips and mouth â¢avoid contact with hair or dyed fabrics including carpet and clothing which may be bleached by this product â¢with other topical acne medicaitons, at the same time nor immediately following use of this product, increased dryness or irritation of the skin may occur. if this occurs, only one medicaiton should be used unless directed by a doctor â¢skin irritaiton may occur, characterized by redness, burning, itching, peeling or possibly swelling. more frequent use or higher concentration may aggravtae skin irritation. mild irritation may be reduced by using the product less frequently or in a lower concentration â¢avoid unnecessary sun exposure and use a sunscreen stop use and ask a doctor â¢if skin irritation becomes severe
Dosage and Administration:
Directions â¢cleanse the skin thoroughly before applying medication â¢cover the entire affected area with a thin layer one to three times a day â¢because excessive drying of the skin may occur, start with one applicaiton daily, then gradually increase to two to three times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day â¢if going outside, apply sunscreen after using this product. if irritation or sensitivity develops, stop use of both products and ask a doctor
Package Label Principal Display Panel:
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Further Questions:
Questions? 1-800-639-3803 weekdays 9 am to 4 pm est