NDC 63629-2030 Selenium Sulfide

Selenium Sulfide

NDC Product Code 63629-2030

NDC CODE: 63629-2030

Proprietary Name: Selenium Sulfide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Selenium Sulfide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat dandruff and a certain scalp infection (seborrheic dermatitis). It reduces itching, flaking, irritation, and redness of the scalp. Selenium sulfide is also used for a condition that causes discoloration of the skin (tinea versicolor). This medication belongs to a class of medications called anti-infectives. It works by slowing the growth of the yeast that causes the infection.

NDC Code Structure

  • 63629 - Bryant Ranch Prepack

NDC 63629-2030-1

Package Description: 1 BOTTLE in 1 CARTON > 180 mL in 1 BOTTLE

NDC Product Information

Selenium Sulfide with NDC 63629-2030 is a a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Selenium Sulfide is selenium sulfide. The product's dosage form is shampoo and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 706548.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Selenium Sulfide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • TRICAPRIN (UNII: O1PB8EU98M)
  • CHROMIC OXIDE (UNII: X5Z09SU859)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • FLUORESCEIN SODIUM (UNII: 93X55PE38X)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • UREA (UNII: 8W8T17847W)
  • PYRITHIONE ZINC (UNII: R953O2RHZ5)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bryant Ranch Prepack
Labeler Code: 63629
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-09-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Selenium Sulfide Product Label Images

Selenium Sulfide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

Manufactured for:Noble Pharmaceuticals LLCCooper City, FL 330241/17

Directions

A liquid antiseborrehic, 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, chromium oxide green, citric acid, cocamidopropyl betaine, D&C yellow #8, diazolidinyl urea, edetate disodium, FD&C red #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, zinc pyrithione.

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.

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.

Contraindications

Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.

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.

Precautions

This medication is to be used as directed by a physician. Not to be used when inflammation or exudation is present as increased absorption may occur.

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.

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.

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

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

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.

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 – 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

Apply to affected areas and lather with a small amount of water. 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.

How Supplied

NDC: 63629-2030-1 Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles

* Please review the disclaimer below.