NDC 69367-229 Selenium Sulfide

Selenium Sulfide

NDC Product Code 69367-229

NDC 69367-229-18

Package Description: 180 mL in 1 BOTTLE

NDC Product Information

Selenium Sulfide with NDC 69367-229 is a a human prescription drug product labeled by Westminster Pharmaceuticals, Llc. The generic name of Selenium Sulfide is selenium sulfide. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Westminster Pharmaceuticals, Llc

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.

  • SELENIUM SULFIDE 22.5 mg/mL

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)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • PYRITHIONE ZINC (UNII: R953O2RHZ5)
  • UREA (UNII: 8W8T17847W)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Westminster Pharmaceuticals, Llc
Labeler Code: 69367
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: 08-19-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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

Description

Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, alpha-tocopherol acetate, ammonium lauryl sulfate, citrus fragrance, cocamidopropyl betaine, Disodium EDTA, FD&C red No. 40, D&C yellow No. 10, methylparaben, panthenol, propylene glycol, propylparaben, purified water, pyrithione zinc, urea, xanthan gum.

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

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Warnings

KEEP OUT OF REACH OF CHILDREN. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.

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.

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.

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.

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 under the age of 12 years 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. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294 or call FDA at 1-800-FDA-1088 or fda.gov/medwatch.

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

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.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 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.NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.

How Supplied

Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles, NDC 69367-229-18.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

* Please review the disclaimer below.