Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask
Salicylic Acid
Amcol Health & Beauty Solutions, Inc. Dba
Human Otc Drug
NDC 68634-058Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask also known as Salicylic Acid is a human otc drug labeled by 'Amcol Health & Beauty Solutions, Inc. Dba'. National Drug Code (NDC) number for Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask is 68634-058. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask drug includes Salicylic Acid - 5 g/2mL . The currest status of Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask drug is Active.
Drug Information:
| Drug NDC: | 68634-058 |
| 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: | Skin Pharmacy Advanced Acne Therapy Pore Refining Facial Mask |
| 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: | Amcol Health & Beauty Solutions, Inc. Dba |
| 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 - 5 g/2mL
|
| 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: | 01 Jul, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | AMCOL Health & Beauty Solutions, Inc. DBA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 68634-058-01 | 1 TUBE in 1 CARTON (68634-058-01) / 99 mL in 1 TUBE | 01 Jul, 2016 | 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
Product Elements:
Skin pharmacy advanced acne therapy pore refining facial mask salicylic acid salicylic acid salicylic acid water kaolin glycerin bentonite butylene glycol cetostearyl alcohol methyl methacrylate/glycol dimethacrylate crosspolymer cocamidopropyl betaine peg-100 stearate magnesium aluminum silicate glyceryl monostearate phenoxyethanol polyoxyl 20 cetostearyl ether xanthan gum chlorphenesin caffeine ethylhexylglycerin edetate disodium citric acid monohydrate sodium hydroxide .alpha.-tocopherol acetate vitamin a palmitate ascorbyl palmitate levomenol
Indications and Usage:
Use for the management of acne
Warnings:
Warnings for external use only when using this product 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. avoid contact with eye. if contact occurs, flush thoroughly with water. in case of accidental ingestion, get medical help or contact a poison control center immediately. keep out of reach of children. do not swallow. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product 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. avoid contact with eye. if contact occurs, flush thoroughly with water. in case of accidental ingestion, get medical help or contact a poison control center immediately.
Dosage and Administration:
Directions once to twice per week, apply a generous layer evenly onto cleansed skin avoiding the eye area. leave on for 10 minutes. follow with your favorite skin+pharmacy moisturizer.
Package Label Principal Display Panel:
Principal display panel - 5 g/2 ml carton label skin + pharmacy advanced acne therapy pore refining facial mask with microsponge * technology 0.5% salicylic acid contains anti-inflammatory bisabolol & vitamins a & e helps eliminate & prevent blemishes unclogs pores fragrance- & oil-free formula exclusively at cvs/pharmacy actual size product on side panel 3.3 fl oz (99 ml) principal display panel - 5 g/2 ml carton label
Principal display panel - 5 g/2 ml tube label skin + pharmacy advanced acne therapy pore refining facial mask with microsponge * technology 0.5% salicylic acid contains anti-inflammatory bisabolol & vitamins a & e helps eliminate & prevent blemishes unclogs pores fragrance- & oil-free formula exclusively at cvs/pharmacy actual size product on side panel 3.3 fl oz (99 ml) principal display panel - 5 g/2 ml tube label