Selenium Sulfide
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-152Selenium Sulfide is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Selenium Sulfide is 42192-152. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Selenium Sulfide drug includes Selenium Sulfide - 22.5 mg/mL . The currest status of Selenium Sulfide drug is Active.
Drug Information:
| Drug NDC: | 42192-152 |
| 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: | Acella 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 - 22.5 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: | 12 Jul, 2017 |
| 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: | Acella Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 706548
|
| 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 |
|---|
| 42192-152-06 | 1 BOTTLE in 1 CARTON (42192-152-06) / 180 mL in 1 BOTTLE | 12 Jul, 2017 | 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 ammonium lauryl sulfate caprylic/capric/lauric triglyceride citric acid monohydrate cocamidopropyl betaine chromic oxide fd&c yellow no. 6 distearyl phthalamic acid diazolidinyl urea edetate disodium hypromellose, unspecified magnesium aluminum silicate methylparaben panthenol ppg-2 hydroxyethyl isostearamide propylene glycol propylparaben water fd&c red no. 40 sodium citrate .alpha.-tocopherol acetate titanium dioxide urea pyrithione zinc
Indications and Usage:
Indications & usage: a liquid antiseborrheic, antifungal preparation 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: for external use only. not for ophthalmic use. do not use on broken skin or inflamed areas. if allergic reaction occurs, discontinue use. avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. if accidental contact occurs, rinse thoroughly with water. keep this and all medications out of the reach of children.
Dosage and Administration:
Dosage and administration: shake well before using for seborrheic dermatitis and dandruff: generally 2 applications each week for 2 weeks will control symptoms. subsequently, shampoo may be used less frequently â weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. should not be applied more frequently than necessary to maintain control. for tinea versicolor: wet skin and apply to affected areas. massage gently into skin working to a full lather. allow product to remain on skin for 10 minutes, then rinse thoroughly. repeat procedure once a day for seven days or as directed by a physician.
Contraindications:
Contraindications: contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.
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.
Use in Pregnancy:
Use in pregnancy: category c animal reproduction studies have not been conducted with this medication. it is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.
Pediatric Use:
Pediatric use: safety and effectiveness in children have not been established.
Overdosage:
Overdosage: there are no documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide 2.25% shampoo. 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:
âdescription: a liquid antiseborrheic, antifungal preparation for topical application. each ml of selenium sulfide 2.25% shampoo contains 22.5 mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, citric acid, cocamidopropyl betaine, chromium oxide green, fd&c yellow 8, distearyl phthalic acid amide, diazolidinyl urea, edetate disodium, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, ppg-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, fd&c red 40, sodium citrate, tocopherol acetate, 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:
Pharmacokinetics: the mechanism of action of topically applied selenium sulfide is not yet known.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis: dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.
How Supplied:
How supplied: selenium sulfide 2.25% shampoo is supplied in 6 fluid oz. (180 ml) bottles, ndc 42192-152-06. store at 20°c to 25°c (68°f to 77°f), excursions permitted between 15°c and 30°c (between 59°f and 86°f). brief exposure to temperatures up to 40°c (104°f) may be tolerated provided the mean kinetic temperature does not exceed 25°c (77°f); however, such exposure should be minimized. protect from freezing. all prescription substitutions and / or recommendations using this product shall be made subject to state and federal statutes as applicable. please note: this is not an orange book product and has not been subjected to fda therapeutic equivalency or otherequivalency testing. no representation is made as to generic status or bioequivalency. each person recommending a prescription substitution using this product shall make such recommendations based on each such personâs professional opinion and knowledge, upon evaluating the active ingred
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Package Label Principal Display Panel:
Principal display panel -180 ml bottle ndc 42192-152-06 ârx only â selenium sulfide 2.25% shampoo â6 fluid oz. (180 ml) for topical use only not for opthalmic use bottle label base label