Purifying Clay Mask
Salicylic Acid
Cosmetic Enterprises Ltd
Human Otc Drug
NDC 56152-5012Purifying Clay Mask also known as Salicylic Acid is a human otc drug labeled by 'Cosmetic Enterprises Ltd'. National Drug Code (NDC) number for Purifying Clay Mask is 56152-5012. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Purifying Clay Mask drug includes Salicylic Acid - .5 g/100mL . The currest status of Purifying Clay Mask drug is Active.
Drug Information:
| Drug NDC: | 56152-5012 |
| 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: | Purifying Clay 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: | Cosmetic Enterprises Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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/100mL
|
| 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: | 05 Jul, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | M006 |
| 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: | COSMETIC ENTERPRISES LTD
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 865105
|
| 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 |
|---|
| 56152-5012-1 | 88 mL in 1 TUBE (56152-5012-1) | 05 Jul, 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:
Uses for the treatment of acne penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads helps prevent new acne blemishes, blackheads and whiteheads
Product Elements:
Purifying clay mask salicylic acid salicylic acid salicylic acid kaolin water bentonite chlorella vulgaris butylene glycol alkyl (c12-15) benzoate bilberry levomenol zinc pidolate copper pidolate brassica rapa subsp. oleifera oil starch, corn ledikite cetyl esters wax magnesium aluminum silicate glycerin titanium dioxide lauroyl lysine sodium citrate sodium chloride apple sodium lauroyl sarcosinate xanthan gum citric acid monohydrate phenoxyethanol ethylhexylglycerin allantoin starch, tapioca green tea leaf
Indications and Usage:
Stop use and ask a doctor if skin irritation occurs or gets worse.
Warnings:
Warnings for external use only do not use on broken skin on large areas of the body when using this product 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 use on clean skin. apply a generous layer all over face and neck. leave on for 5-10 minutes. rinse thoroughly. use as often as needed.
Package Label Principal Display Panel:
Clear paula's choice purifying clay mask willowherb & green tea blemish prone skin 88 ml / 3 fl. oz. purifying clay mask