Anti Bac Acne Clearing
Benzoyl Peroxide
Cosmetic Enterprise Ltd
Human Otc Drug
NDC 56152-4012Anti Bac Acne Clearing also known as Benzoyl Peroxide is a human otc drug labeled by 'Cosmetic Enterprise Ltd'. National Drug Code (NDC) number for Anti Bac Acne Clearing is 56152-4012. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Anti Bac Acne Clearing drug includes Benzoyl Peroxide - 5 g/100mL . The currest status of Anti Bac Acne Clearing drug is Active.
Drug Information:
| Drug NDC: | 56152-4012 |
| 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: | Anti Bac Acne Clearing |
| 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: | Benzoyl Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cosmetic Enterprise Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 5 g/100mL
|
| 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: | 14 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| 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: | Cosmetic Enterprise Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106309
1541091
|
| 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 |
|---|
| 56152-4012-1 | 50 mL in 1 BOTTLE (56152-4012-1) | 14 Jan, 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:
Use for the treatment of acne helps keep skin clear of new acne blemishes
Product Elements:
Anti bac acne clearing benzoyl peroxide peg-40 stearate benzoyl peroxide benzoyl peroxide water ppg-2 myristyl ether propionate serenoa repens whole sesame seed sodium ascorbate sodium hydroxide edetic acid phenoxyethanol edetate sodium edetic acid ethylhexylglycerin sorbitan monostearate hydrogenated methyl abietate methyl methacrylate/glycol dimethacrylate crosspolymer carboxypolymethylene glyceryl monostearate cetyl alcohol hydrogenated soybean lecithin cholesterol ceramide ns dilaurate ceramide np oleic acid palmitic acid
Indications and Usage:
Stop use and ask a doctor if irritation becomes severe.
Warnings:
Warnings for external use only when using this product using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by a doctor. do not use this product if you have very sensitive skin or if you are sensitive to benzoyl peroxide. avoid unnecesary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth. avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. irritation may be reduced by using the product less frequently or in a lower concentration.
Dosage and Administration:
Directions clease skin thoroughly before applying. cover the affected area with a thin layer 1 to 3 days. because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day. if going outside apply sunscreen after using this product. if irritation or sensitivity develops, stop use of products and ask a doctor.
Package Label Principal Display Panel:
Kate somerville acne/peau acneique 5% benzoyl peroxide anti bac acne clearing lotion lotion purifiante actibacterienne 50ml 1.7 fl oz liq acne label