Selenium Sulfide
Kmm Pharmaceuticals, Llc
Human Prescription Drug
NDC 52187-550Selenium Sulfide is a human prescription drug labeled by 'Kmm Pharmaceuticals, Llc'. National Drug Code (NDC) number for Selenium Sulfide is 52187-550. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Selenium Sulfide drug includes Selenium Sulfide - 23 mg/mL . The currest status of Selenium Sulfide drug is Active.
Drug Information:
| Drug NDC: | 52187-550 |
| 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: | Selenium Sulfide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Selenium Sulfide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kmm Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Shampoo |
| 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: | SELENIUM SULFIDE - 23 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: | UNAPPROVED DRUG OTHER |
| 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: | 28 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 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. |
| 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: | KMM Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1436940
|
| 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: | Z69D9E381Q
|
| 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 |
|---|
| 52187-550-06 | 180 mL in 1 BOTTLE, PLASTIC (52187-550-06) | 28 Feb, 2022 | 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. |
Product Elements:
Selenium sulfide selenium sulfide selenium sulfide selenium sulfide tan orange
Indications and Usage:
Indications: this product is a liquid antiseborrheic, antifungal preparation useful for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. urea hydrates and is useful for conditions such as dry scalp.
Warnings:
Warnings: keep out of reach of children.
Dosage and Administration:
Dosage and administration: shake well before use. for seborrheic dermatitis and dandruff: wet skin and apply to areas to be cleansed. massage gently into the skin working into a full lather. rinse thoroughly and pat dry. generally, two applications each week for two weeks will control symptoms. subsequently, shampoo may be used less frequently or as directed by a physician. it should not be applied more frequently than necessary to maintain control. for tinea versicolor: wet skin and apply to areas to be cleansed. massage gently into the skin working into a full lather. allow product to remain on skin for ten minutes, then rinse thoroughly and pat dry. repeat procedure once a day for seven days or as directed by a physician.
Contraindications:
Contraindications: this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions:
Adverse reactions: in decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). as with other shampoos, oiliness or dryness of hair and scalp may occur.
Overdosage:
Overdosage: there are no documented reports of serious toxicity in humans resulting from acute ingestion of this product. however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. evacuation of the stomach contents should be considered in cases of acute oral ingestion.
Description:
Description: each ml contains 23 mg of selenium sulfide in a vehicle consisting of: d&c yellow #8, fd&c red #40, fragrance, methyl paraben, peg-150 pentaerythrityl tetrastearate (and) aqua (and) peg-6 caprylic/capric glycerides, propyl paraben, propylene glycol, purified water, sodium chloride, sodium laureth sulfate (and) cocamidopropyl betaine (and) sodium lauryl sulfate (and) cocamide mipa, titanium dioxide, urea and zinc pyrithione.
Clinical Pharmacology:
Clinical pharmacology: selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production. pharmacokinetics: the mechanism of action of topically applied selenium sulfide is not yet known.
How Supplied:
How supplied: this product is supplied in the following size(s): 6 fl. oz. (180 ml) bottles, ndc 52187-550-06 to report a serious adverse event or obtain product information, call 1-855-899-4237. distributed by: kmm pharmaceuticals, llc 1000 n. west street suite 1200, #1021 wilmington, de 19801 2100535 [00] rev. 11/2021
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