NDC 70000-0531 Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff

Selenium Sulfide

NDC Product Code 70000-0531

NDC CODE: 70000-0531

Proprietary Name: Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff 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

  • 70000 - Cardinal Health

NDC 70000-0531-1

Package Description: 207 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff with NDC 70000-0531 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff is selenium sulfide. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Cardinal Health

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 Otc 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.

Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff 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 10 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.

  • WATER (UNII: 059QF0KO0R)
  • AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

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.
  • 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: Cardinal Health
Labeler Code: 70000
FDA Application Number: part358H What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-05-2019 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.

Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff Product Label Images

Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff 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

Drug Facts

DIST BY CAH, DUBLIN, OH 43017

Active Ingredient

Selenium Sulfide 1%

Purpose

Anti-seborrheic dermatitis, anti-dandruff

Uses

For the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

Warnings

For external use only

As A Doctor Before Use If

  • ♦condition covers a large area of the body.

When Using This Product

  • ♦avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.♦for color-treated or permed hair, rinse thoroughly.

Stop Use And Ask A Doctor If

  • ♦condition worsens or does not improve after regular use of this product as directed.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • ♦shake well♦shampoo, then rinse thoroughly♦for best results, use at least twice a week or as directed by a doctor.

Other Information

Store at room temperature

Inactive Ingredients

Water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33

* Please review the disclaimer below.