Rugby Benzoyl Peroxide Wash Acne Medication
Benzoyl Peroxide
Rugby Laboratories
Human Otc Drug
NDC 0536-1259Rugby Benzoyl Peroxide Wash Acne Medication also known as Benzoyl Peroxide is a human otc drug labeled by 'Rugby Laboratories'. National Drug Code (NDC) number for Rugby Benzoyl Peroxide Wash Acne Medication is 0536-1259. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Rugby Benzoyl Peroxide Wash Acne Medication drug includes Benzoyl Peroxide - 50 mg/mL . The currest status of Rugby Benzoyl Peroxide Wash Acne Medication drug is Active.
Drug Information:
| Drug NDC: | 0536-1259 |
| 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: | Rugby Benzoyl Peroxide Wash Acne Medication |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Rugby Benzoyl Peroxide Wash |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Acne Medication |
| 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: | Rugby Laboratories |
| 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 - 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: | 17 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | Rugby Laboratories
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 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. |
| 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 |
|---|
| 0536-1259-19 | 236 mL in 1 BOTTLE, DISPENSING (0536-1259-19) | 17 Dec, 2019 | N/A | No |
| 0536-1259-63 | 148 mL in 1 BOTTLE, DISPENSING (0536-1259-63) | 17 Dec, 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:
Purpose acne medication
Product Elements:
Rugby benzoyl peroxide wash acne medication benzoyl peroxide benzoyl peroxide benzoyl peroxide carbomer homopolymer, unspecified type cetyl alcohol edetate disodium disodium laureth sulfosuccinate glycerin glyceryl monostearate laureth-7 magnesium aluminum silicate peg-100 stearate propylene glycol sodium coco-sulfate sodium lauroamphoacetate water xanthan gum
Indications and Usage:
Use for the treatment of acne
Warnings:
Warnings for external use only. do not use if you have very sensitive 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 consult a doctor if irritation becomes severe if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) immediately.
Do Not Use:
Warnings for external use only. do not use if you have very sensitive 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 consult a doctor if irritation becomes severe if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center (1-800-222-1222) immediately.
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.
Dosage and Administration:
Directions shake well wet area to be cleansed sensitive 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 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. if irritation or sensitivity develops, stop use of both products and ask a doctor.
Stop Use:
Stop use and consult a doctor if irritation becomes severe
Package Label Principal Display Panel:
Principal display panel - 236 ml bottle label rugby ® ndc 0536-1259-19 benzoyl peroxide wash usp 5% helps to keep skin clear helps dry oily skin helps clear acne pimples 8 fl oz (236 ml) principal display panel - 236 ml bottle label
Further Questions:
Questions or comments? 1-800-645-2158