Benzepro
Benzoyl Peroxide
Prugen, Inc.
Human Prescription Drug
NDC 42546-016Benzepro also known as Benzoyl Peroxide is a human prescription drug labeled by 'Prugen, Inc.'. National Drug Code (NDC) number for Benzepro is 42546-016. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Benzepro drug includes Benzoyl Peroxide - 60 mg/1 . The currest status of Benzepro drug is Active.
Drug Information:
| Drug NDC: | 42546-016 |
| 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: | Benzepro |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Prugen, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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 - 60 mg/1
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 01 Aug, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 Jan, 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. |
| 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: | PruGen, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797704
1605441
|
| 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 |
|---|
| 42546-016-60 | 60 PACKET in 1 CARTON (42546-016-60) / 1 CLOTH in 1 PACKET | 01 Aug, 2015 | 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. |
Product Elements:
Benzepro benzoyl peroxide benzoyl peroxide benzoyl peroxide water carbomer copolymer type b (allyl pentaerythritol crosslinked) hyaluronate sodium cetyl alcohol glycerin hypromellose 2910 (15 mpa.s) sodium cocoyl isethionate sodium methyl cocoyl taurate sodium lauryl sulfoacetate disodium laureth sulfosuccinate sodium pyrrolidone carboxylate sodium hydroxide zinc lactate citric acid monohydrate sodium citrate, unspecified form docusate sodium
Indications and Usage:
Indications and usage benzepro ® foaming cloths are indicated for use in the topical treatment of mild to moderate acne vulgaris.
Warnings:
Warnings for external use only. not for ophthalmic use. keep out of the reach of children. if swallowed, get medical help or contact a poison control center right away. when using this product, skin irritation and dryness is more likely to occur if: you leave benzepro ® foaming cloths on your skin longer than directed you use another topical acne medication at the same time do not use this product if you: have very sensitive skin are sensitive to benzoyl peroxide when using this product: avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, 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 possibly swelling. irritation may be reduced by using the product less frequently or in lower concentration. stop use and ask a doctor: if irritation becomes severe.
General Precautions:
General if severe irritation develops, discontinue use and institute appropriate therapy.
Dosage and Administration:
Directions avoid contact with hair, fabrics or carpeting as benzoyl peroxide will cause bleaching or discoloration. wash affected areas once or twice daily, or as directed by your physician. wet face with water. wet cloth with a little waterand work into a full lather. cleanse face with cloth for 10-20 seconds avoiding eyes. rinse thoroughly and pat dry. throw away cloth. do not flush. if going outside, apply sunscreen after using this product. if irritation or sensitivity develops, stop use of both products and ask a doctor.
Contraindications:
Contraindications benzepro ® foaming cloths should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product. discontinue use if hypersensitivity is observed.
Adverse Reactions:
Adverse reactions allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with benzoyl peroxide. it is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. benzoyl peroxide should be used by a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in children below the age of 12 have not been established.
Overdosage:
Overdosage if excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued. to hasten resolution of the adverse effects, cool compresses may be used. after symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
Description:
Description benzepro ® foaming cloths are a topical preparation containing 6.0% benzoyl peroxide. each gram of benzepro ® foaming cloths wash contains 60 mg of benzoyl peroxide as micronized particles. ingredients include purified water, carbomer 1342, sodium hyaluronate, cetyl alcohol, glycerine, hydroxypropyl methylcellulose, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, sodium pca, sodium hydroxide 10% solution, zinc lactate, citric acid, sodium citrate, benzoyl peroxide 6.0%, docusate sodium. benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. benzoyl peroxide (c 14 h 10 o 4 ) is represented by the following structure: chemical structure
Clinical Pharmacology:
Clinical pharmacology the exact method of action of benzoyl peroxide in acne vulgaris is not known. benzoyl peroxide is an antibacterial agent with demonstrated activity against propionibacterium acnes. this action, combined with the mild keratolytic effect of benzoyl peroxide, is believed to be responsible for its usefulness in acne. benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. however, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. the clinical significance of the findings is not known.
How Supplied:
How supplied benzepro ® foaming cloths are supplied in a carton containing 60 à 3.2 g individually wrapped benzoyl peroxide 6% foaming cloths (ndc 42546-016-60). store at room temperature: 15° - 25°c (59° - 77°f). protect from freezing.
Information for Patients:
Information for patients this medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. avoid contact with eyes, eyelids, lips, and mucous membranes. if accidental contact occurs, rinse with water. if excessive redness or irritation develops, discontinue use and consult your physician.
Package Label Principal Display Panel:
Principal display panel - 60 cloth packet carton ndc 42546-016-60 rx only benzepro ® foaming cloths benzoyl peroxide 6.0% 60 cloths net wt. 3.2 g each prugen pharmaceuticals principal display panel - 60 cloth packet carton