Benzoyl Peroxide
Burel Pharmaceuticals, Llc
Human Otc Drug
NDC 35573-453Benzoyl Peroxide is a human otc drug labeled by 'Burel Pharmaceuticals, Llc'. National Drug Code (NDC) number for Benzoyl Peroxide is 35573-453. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Benzoyl Peroxide drug includes Benzoyl Peroxide - 50 mg/mL . The currest status of Benzoyl Peroxide drug is Active.
Drug Information:
| Drug NDC: | 35573-453 |
| 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: | Benzoyl Peroxide |
| 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: | Burel Pharmaceuticals, Llc |
| 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: | BENZOYL PEROXIDE - 50 mg/mL
|
| 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: | 15 Apr, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | Burel Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 142034
308696
|
| 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. |
| UPC: | 0335573453916
0335573453084
0335573454081
0335573454913
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 35573-453-08 | 237 mL in 1 BOTTLE (35573-453-08) | 15 Apr, 2022 | N/A | No |
| 35573-453-91 | 148 mL in 1 BOTTLE (35573-453-91) | 15 Apr, 2022 | 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:
Benzoyl peroxide benzoyl peroxide benzoyl peroxide benzoyl peroxide cetyl alcohol disodium oleamido monoethanolamine sulfosuccinate edetate disodium glycerin laureth-12 magnesium aluminum silicate propylene glycol water sodium coco-sulfate sodium lauroamphoacetate xanthan gum viscous benzoyl peroxide benzoyl peroxide benzoyl peroxide benzoyl peroxide cetyl alcohol disodium oleamido monoethanolamine sulfosuccinate edetate disodium glycerin laureth-12 magnesium aluminum silicate propylene glycol water sodium coco-sulfate sodium lauroamphoacetate xanthan gum viscous
Indications and Usage:
Use for the treatment of acne
Warnings:
Warnings: for external use only. avoid contact with eyes, eyelids, lips and mucous membranes. do not use 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 eyes, lips, and mouth. avoid contact with hair or 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 a lower concentration. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. stop use and ask a doctor if irritation becomes severe. keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings: for external use only. avoid contact with eyes, eyelids, lips and mucous membranes. do not use 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 eyes, lips, and mouth. avoid contact with hair or 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 a lower concentration. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. stop use and ask a doctor if irritation becomes severe. keep out of reach of children if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid unnecessary sun exposure and use a sunscreen. avoid contact with eyes, lips, and mouth. avoid contact with hair or 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 a lower concentration. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne medication at a time. stop use and ask a doctor if irritation becomes severe.
Dosage and Administration:
Directions shake well. clean the skin thoroughly before applying this product. sensitivity test for a new user. apply product sparingly to one or two small affected areas during the first 3 days. if no discomfort occurs,follow the directions stated below. one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 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. if going outside, apply sunscreen after using this product. follow directions in the sunscreen labeling. if irritation or sensitivity develops stop use of both products and ask a doctor.
Package Label Principal Display Panel:
Principal display panel - 5% 5oz (148 g) bottle label ndc 35573-453-91 benzoyl peroxide topical wash 5% for topical use only net weight 5 oz (148 g) burelpharma 5oz 5%
Principal display panel - 5% 8oz (237 g) bottle label ndc 35573-453-08 benzoyl peroxide topical wash 5% for topical use only net weight 8 oz (237 g) burelpharma 5% 8oz
Principal display panel - 10% 5oz (148 g) bottle label ndc 35573-454-91 benzoyl peroxide topical wash 10% for topical use only net weight 5 oz (148 g) burelpharma 10% 5oz
Prinicipal display panel - 10% 8oz (237 g) bottle label ndc 35573-454-08 benzoyl peroxide topical wash 10% for topical use only net weight 8 oz (237 g) burelpharma 10% 8oz