Exuviance Daily Acne Peel
Salicylic Acid
Neostrata Company Inc.
Human Otc Drug
NDC 58414-0017Exuviance Daily Acne Peel also known as Salicylic Acid is a human otc drug labeled by 'Neostrata Company Inc.'. National Drug Code (NDC) number for Exuviance Daily Acne Peel is 58414-0017. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Exuviance Daily Acne Peel drug includes Salicylic Acid - 20 mg/mL . The currest status of Exuviance Daily Acne Peel drug is Active.
Drug Information:
| Drug NDC: | 58414-0017 |
| 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: | Exuviance Daily Acne Peel |
| 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: | Neostrata Company Inc. |
| 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: | SALICYLIC ACID - 20 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 Jun, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jun, 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: | NeoStrata Company Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 251577
|
| 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: | O414PZ4LPZ
|
| 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 |
|---|
| 58414-0017-2 | 1 BOTTLE, PLASTIC in 1 CARTON (58414-0017-2) / 100 mL in 1 BOTTLE, PLASTIC | 01 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 treatment
Product Elements:
Exuviance daily acne peel salicylic acid salicylic acid salicylic acid alcohol diisopropyl adipate cyclomethicone 5 triethyl citrate propylene glycol cyclomethicone 6 citric acid monohydrate tartaric acid butylated hydroxytoluene
Indications and Usage:
Uses clears acne blemishes, acne pimples, blackheads and whiteheads allows skin to heal helps prevent new acne blemishes from forming
Warnings:
Warnings for external use only do not use during pregnancy/lactation keep out of eyes rinse with water to remove when using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. only one drug should be used unless directed by a doctor stop use and ask a doctor if too much skin irritation or sensitivity develops or increases keep out of reach of children. if swallowed, get medical help or contact a poison control center right away flammable- keep away from fire or flame
Do Not Use:
Warnings for external use only do not use during pregnancy/lactation keep out of eyes rinse with water to remove when using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. only one drug should be used unless directed by a doctor stop use and ask a doctor if too much skin irritation or sensitivity develops or increases keep out of reach of children. if swallowed, get medical help or contact a poison control center right away flammable- keep away from fire or flame
When Using:
When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. only one drug should be used unless directed by a doctor
Dosage and Administration:
Directions clean the skin thoroughly before applying medication using a cotton pad, cover the affected area with a thin layer 1 to 3 times daily, avoiding eye area because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor if bothersome peeling or dryness occurs, reduce applications to once a day or every other day for new users, apply product sparingly with pad to 1 or 2 small affected areas for approximately 3 days. if no discomfort occurs, follow directions above wash hands after applying
Stop Use:
Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases
Package Label Principal Display Panel:
Principal display panel - 100 ml bottle carton exuviance ® focus oily acne prone daily acne peel clear blemishes, black/white-heads formulated to smooth texture, reduce oiliness 2% salicylic acid acne solution citric acid and tartaric acid citrafill 100 ml/3.4 fl oz principal display panel - 100 ml bottle carton
Further Questions:
Questions or comments? call toll free 1-800-225-9411 (9am-5pm et)