Selenium Sulfide
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-1148Selenium Sulfide is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Selenium Sulfide is 63629-1148. 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: | 63629-1148 |
| 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: | Bryant Ranch Prepack |
| 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: | 01 Jun, 2015 |
| 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, 2024 |
| 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: | Bryant Ranch Prepack
|
| 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. |
| 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 |
|---|
| 63629-1148-1 | 180 mL in 1 BOTTLE (63629-1148-1) | 02 Oct, 2020 | 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 distearyl phthalamic acid edetate disodium fd&c red no. 40 hypromellose, unspecified magnesium aluminum silicate methylparaben panthenol ppg-2 hydroxyethyl coco/isostearamide propylene glycol propylparaben water sodium citrate, unspecified form titanium dioxide .alpha.-tocopherol acetate urea pyrithione zinc selenium sulfide selenium sulfide ammonium lauryl sulfate medium-chain triglycerides chromic oxide citric acid monohydrate cocamidopropyl betaine fluorescein sodium diazolidinyl urea
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: keep out of reach of children. for external use only. not for ophthalmic use.
General Precautions:
General: this product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. if redness or irritation occurs, discontinue use and consult a physician.
Dosage and Administration:
Dosage and administration: shake well before using 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.
Use in Pregnancy:
Pregnancy: category c. animal reproduction studies have not been conducted with this product. it is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.
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:
Description: each ml of selenium sulfide 2.25% shampoo contains 22.5mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide green, citric acid, cocamidopropyl betaine, d&c yellow no. 8, diazolidinyl urea, distearyl phthalic acid amide, edetate disodium, fd&c red no. 40, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, ppg-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide, tocopheryl acetate, 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, mutagenesis and impairment of fertility: dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects. studies on reproduction and fertility also have not been performed.
How Supplied:
How supplied: selenium sulfide 2.25% shampoo is supplied in 180 ml bottles, ndc 63629-1148-1. keep this and all medications out of the reach of children.
Information for Patients:
Information for patients: patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. avoid contact with eyes, lips and mucous membranes. if accidental contact occurs, rinse thoroughly with water. do not use on broken skin or inflamed areas.
Package Label Principal Display Panel:
Selenium sulfide external shampoo 2.25 % label