Patchology The Blemish Buster Breakout Box 3-in-1 Acne Treatment
Salicylic Acid
Rare Beauty Brands, Inc.
Human Otc Drug
NDC 72204-001Patchology The Blemish Buster Breakout Box 3-in-1 Acne Treatment also known as Salicylic Acid is a human otc drug labeled by 'Rare Beauty Brands, Inc.'. National Drug Code (NDC) number for Patchology The Blemish Buster Breakout Box 3-in-1 Acne Treatment is 72204-001. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Patchology The Blemish Buster Breakout Box 3-in-1 Acne Treatment drug includes . The currest status of Patchology The Blemish Buster Breakout Box 3-in-1 Acne Treatment drug is Active.
Drug Information:
| Drug NDC: | 72204-001 |
| 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: | Patchology The Blemish Buster Breakout Box 3-in-1 Acne Treatment |
| 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: | Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rare Beauty Brands, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 01 Sep, 2018 |
| 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: | Rare Beauty Brands, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1994404
|
| 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: | |
| 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 |
|---|
| 72204-001-11 | 1 KIT in 1 BOX (72204-001-11) * 24 PATCH in 1 PACKET / .5 g in 1 PATCH * 3 STRIP in 1 PACKAGE | 01 Sep, 2018 | 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 treatment
Product Elements:
Patchology the blemish buster breakout box 3-in-1 acne treatment salicylic acid pimple-shrinking salicylic acid dots salicylic acid phytosphingosine phenoxyethanol polysorbate 80 povidone salicylic acid salicylic acid butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) alcohol epilobium angustifolium whole hyaluronate sodium vitis vinifera seed butylene glycol water melaleuca alternifolia leaf sodium metabisulfite bisulfite ion blackhead-eliminating nose strips hamamelis virginiana whole copovidone k25-31 bentonite activated charcoal povidone, unspecified water glycerin polyvinyl alcohol, unspecified titanium dioxide kaolin phenoxyethanol butylene glycol potassium sorbate 1,2-hexanediol aloe vera leaf menthol sodium hydroxide sodium dehydroacetate glycyrrhizinate dipotassium
Indications and Usage:
Use for the treatment of acne
Warnings:
Warnings for external use only. skin irritation and dryness is likely to occur if you use another topical acne product at the same time. if irritation occurs, only one medication should be used.
Do Not Use:
Warnings for external use only. skin irritation and dryness is likely to occur if you use another topical acne product at the same time. if irritation occurs, only one medication should be used.
Dosage and Administration:
Directions cleanse thoroughly before applying medication. apply the sticker on the affected areas. if bothersome dyrness or peeling occurs, reduce application to once a day or even every other day. sensitivity test for a new user: apply product to one or two small affected areas during the first 3 days.
Package Label Principal Display Panel:
The blemish buster breakout box 3-in-1 acne treatment kit 24 pimple-shrinking salicylic acid dots 24 whitehead-absorbing hydrocolloid dots 3 blackhead-eliminating nose strips box
Further Questions:
Questions or comments? call toll free 1-888-243-0646 report serious adverse reactions to: 220 norwood park south suite 2203 norwood, ma 02062