NDC 50718-0021 Control Dandruff Therapy

Dandruff Therapy Shampoo

NDC Product Code 50718-0021

NDC 50718-0021-1

Package Description: 200 mL in 1 BOTTLE

NDC Product Information

Control Dandruff Therapy with NDC 50718-0021 is a a human over the counter drug product labeled by Kamedis. The generic name of Control Dandruff Therapy is dandruff therapy shampoo. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Kamedis

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.

Control Dandruff Therapy 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 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.

  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • WATER (UNII: 059QF0KO0R)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
  • POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)

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: Kamedis
Labeler Code: 50718
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: 01-01-2018 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: 12-31-2021 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.

Control Dandruff Therapy Product Label Images

Control Dandruff Therapy 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 Ingredient

Pyrithione Zinc 1.0%

Purpose

Anti-Dandruff

Use

  • Helps eliminate scalp itching, irritation, redness, flaking, and scaling associated with dandruff

Warnings

For external use only

When Using This Product

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

Stop Use And Ask A Doctor If

  • If condition worsens or does not improve after regular use of this product as directed, consult a doctor

Keep Out Of Reach Of Children

  • If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply to wet hairGently massage into hair and scalp and leave for 2-3 minutes before thoroughly rinsingRinse and repeat if desiredFor best results use at least twice a week or as directed by your doctor

Inactive Ingredients

Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Fragrance, Polyquaternium-10, Salicylic Acid, Salt(Sodium Chloride), Soapberry (Sapindus Mukurossi) Fruit Extract, Sodium Benzoate, Sodium Lauroyl Sarcosinate, Triethanolamine, Water.

* Please review the disclaimer below.