Clear Acne Face Cleanser
Acne Face Cleanser
Kamedis
Human Otc Drug
NDC 50718-0031Clear Acne Face Cleanser also known as Acne Face Cleanser is a human otc drug labeled by 'Kamedis'. National Drug Code (NDC) number for Clear Acne Face Cleanser is 50718-0031. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Clear Acne Face Cleanser drug includes Salicylic Acid - 14.4 mg/mL . The currest status of Clear Acne Face Cleanser drug is Active.
Drug Information:
| Drug NDC: | 50718-0031 |
| 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: | Clear Acne Face Cleanser |
| 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: | Acne Face Cleanser |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kamedis |
| 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 - 14.4 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: | 01 Jan, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | Kamedis
|
| 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. |
| UPC: | 0893353000250
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 50718-0031-1 | 1 BOTTLE in 1 CARTON (50718-0031-1) / 100 mL in 1 BOTTLE | 01 Jan, 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:
Clear acne face cleanser acne face cleanser salicylic acid salicylic acid benzyl alcohol purslane chlorphenesin glycerin propanediol water xanthan gum sodium hydroxide squalane cocamidopropyl betaine glyceryl stearate se coco monoethanolamide lauroyl lysine myristic acid sodium chloride sapindus mukorossi fruit sodium lauroyl methyl isethionate sodium methyl cocoyl taurate stearic acid edetate sodium trisodium ethylenediamine disuccinate .alpha.-tocopherol acetate hydrolyzed jojoba esters (acid form) sodium cocoyl apple amino acids methyl glucose
Indications and Usage:
Use for the treatment of acne
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with the eyes. if contact occurs, rinse eyes thoroughly with water using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. if this occurs, only one medication at a time should be used, unless otherwise directed by a doctor.
Dosage and Administration:
Directions wet face. apply cleanser to hands, add water and work into lather. gently massage all over face avoiding eye area. rinse thoroughly and pat dry. good for daily use. cover the entire affected area with a thin layer 1 to 3 times daily. because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor. if bothersome dryness or peeling occurs, reduce application to once a day or every other day. for children under 10 years of age and under, consult your doctor.
Stop Use:
Stop use and ask a doctor if irritation persists
Package Label Principal Display Panel:
Carton label image description
Further Questions:
Questions or comments? 1-855-626-6606