Acne Treatment System
Benzoyl Peroxide, Salicylic Acid
Vivier Pharma, Inc.
Human Otc Drug
NDC 67226-3026Acne Treatment System also known as Benzoyl Peroxide, Salicylic Acid is a human otc drug labeled by 'Vivier Pharma, Inc.'. National Drug Code (NDC) number for Acne Treatment System is 67226-3026. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Acne Treatment System drug includes . The currest status of Acne Treatment System drug is Active.
Drug Information:
| Drug NDC: | 67226-3026 |
| 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: | Acne Treatment System |
| 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, Salicylic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vivier Pharma, 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: | 11 Nov, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | Vivier Pharma, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 106309
562600
1092658
|
| 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 |
|---|
| 67226-3026-9 | 1 KIT in 1 KIT (67226-3026-9) * 1 TUBE in 1 BOX (67226-2050-3) / 30 mL in 1 TUBE * 150 mL in 1 BOTTLE, PUMP (67226-1021-1) | 11 Nov, 2017 | 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:
Acne treatment system benzoyl peroxide, salicylic acid acne treatment benzoyl peroxide c13-14 isoparaffin ethylhexylglycerin lanolin oil laureth-4 laureth-7 magnesium aluminum silicate phenoxyethanol propylene glycol water xanthan gum benzoyl peroxide benzoyl peroxide medicated wash salicylic acid butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) alcohol citric acid monohydrate disodium cocoamphodiacetate disodium cocoyl glutamate dmdm hydantoin diethylene glycol monoethyl ether hexamidine diisethionate peg-7 glyceryl cocoate peg-120 methyl glucose dioleate sodium hydroxide sodium lauroyl sarcosinate water salicylic acid salicylic acid
Indications and Usage:
Use for the treatment of acne. dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.
Warnings:
Warnings for external use only. ask a doctor before use if you are 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. when using this product do not get into eyes. stop use and ask a doctor if excessive skin irritation develops or increases. keep out of reach of children. if swallowed, get medical help or contact poison control center right away.
When Using:
When using this product do not get into eyes.
Dosage and Administration:
Directions wet face using lukewarm water. gently massage over face using fingertips. rinse completely. use both morning and night or as directed by a physician. if dryness or peeling occurs, reduce application to once a day or every other day.
Stop Use:
Stop use and ask a doctor if excessive skin irritation develops or increases.
Package Label Principal Display Panel:
Package labeling: updated outer box updated outer box 2 30ml acne treatment lotion 150ml medicated wash
Further Questions:
Questions? 450 455 9779 1 877 484 8437