NDC 74553-003 Dandruff

Pyrithione Zinc

NDC Product Code 74553-003

NDC 74553-003-01

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dandruff with NDC 74553-003 is a a human over the counter drug product labeled by Xtreme Tools International, Inc. The generic name of Dandruff is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Xtreme Tools International, Inc

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.

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.

  • PYRITHIONE ZINC 2 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.

  • ARGAN OIL (UNII: 4V59G5UW9X)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • PPG-10 CETYL ETHER (UNII: Q056X4917J)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
  • COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN (1000 MW) (UNII: 8V0I3U3HMO)
  • POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
  • ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • VINYL NEODECANOATE (UNII: 9NDY01YYPT)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CHITOSAN SUCCINAMIDE (1300 MPA.S) (UNII: 41164V2SNS)

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: Xtreme Tools International, Inc
Labeler Code: 74553
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: 10-06-2020 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 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.

Dandruff Product Label Images

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

Active Ingredient

Pyrithione zinc 2%

Purpose

Anti-dandruff

Use

Helps prevent itching and flaking associated with dandruff.

Warning

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help, or contact a Poison Control Center right away.

Directions

  • Shake wellFor best results use at least twice a week or as directed by a doctor

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide MEA, Glycol Distearate, Polysorbate 20,PPG-10 Cetyl Ether, PEG-8, Polyquaternium-10, Acrylates, Vinyl Neodecanoate, Crosspolymer, Hydrolyzed Wheat Protein, Ricinus Communis (Castor) Seed Oil, Hydrolyzed Keratin, Chitosan Succinamide, Argania Spinosa (Argan) Kemel Oil, Olea Europaea (Olive) Oil, Sodium Benzoate, Pottassium Sorbate, Fragrance, Citric Acid, CI 42090

* Please review the disclaimer below.