NDC 69282-008 Sebastian Purist Antidandruff

Pyrithione Zinc

NDC Product Code 69282-008

NDC Code: 69282-008

Proprietary Name: Sebastian Purist Antidandruff 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: Pyrithione Zinc 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.

NDC Code Structure

  • 69282 - The Wella Corporation
    • 69282-008 - Sebastian Purist Antidandruff

NDC 69282-008-10

Package Description: 250 mL in 1 BOTTLE

NDC Product Information

Sebastian Purist Antidandruff with NDC 69282-008 is a a human over the counter drug product labeled by The Wella Corporation. The generic name of Sebastian Purist Antidandruff is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: The Wella Corporation

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.

Sebastian Purist Antidandruff 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.

  • PYRITHIONE ZINC 1 g/100mL

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.

  • CAFFEINE (UNII: 3G6A5W338E)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SULFITE ION (UNII: 15744271E9)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-3 DISTEARATE (UNII: 8420ECX438)
  • SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ALLANTOIN (UNII: 344S277G0Z)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ)
  • MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: The Wella Corporation
Labeler Code: 69282
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: 06-27-2019 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.

Sebastian Purist Antidandruff 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

Active Ingredients

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

Helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only.

When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If

Condition worsens or does not improve after regular use of this product as directed.

Directions

For best results use at least twice a week or as directed by a doctor.Apply a small amount evenly over wet scalp and hair. Leave on for several minutes. Rinse well.

* Please review the disclaimer below.

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