NDC 73528-400 Treatment

Zinc Pyrithione

NDC Product Code 73528-400

NDC 73528-400-01

Package Description: 100 mL in 1 TUBE

NDC 73528-400-02

Package Description: 30 mL in 1 TUBE

NDC 73528-400-03

Package Description: 5 mL in 1 PACKET

NDC Product Information

Treatment with NDC 73528-400 is a a human over the counter drug product labeled by No Flakes Given, Llc.. The generic name of Treatment is zinc pyrithione. The product's dosage form is cream and is administered via topical form.

Labeler Name: No Flakes Given, Llc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Treatment 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 .125 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.

  • WATER (UNII: 059QF0KO0R)

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: No Flakes Given, Llc.
Labeler Code: 73528
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: 02-01-2020 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.

Treatment 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

Otc - Active Ingredient

Zinc Pyrithione 0.125%

Otc - Purpose

Anti-Dandruff

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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, call a poinson control center or get medical help right away.
Do not use on children under 2 years of age, unless directed by a doctor.

Indications & Usage

For the relief of symptoms from scalp itch, irritation, flaking and redness associated with dandruff.

Dosage & Administration

Apply to affected areas 1 to 4 times daily or as directed by a doctor.Apply liberally tyo damp or dry scalp, and gently massage with fingertips. Do not rinse off.

Otc - Questions

1-877-No-Flake (1-877-663-5253)

Inactive Ingredient

Water (Aqua), Aloe Barbadensis (Aloe Vera) Leaf Juice, Propanediol, Glycerin, Carthamus Tinctorius (Safflower) Seed Oil, Mentha Aquatica Leaf Oil, Mentha Arvensis (Cornmint) Leaf Oil, Salicylic Acid, Camellia Sinensis Leaf Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Niacinamide, Panthenol, Lavandula Angustifolia (Lavender) Oil, Allium Sativum (Garlic) Bulb Extract, Yeast Ferment Extract, Cocos Nucifera (Coconut) Oil, Citrus Reticulata (Tangerine) Peel Oil, Foeniculum Vulgare (Fennel) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Vanillin, Cetearamidoethyldiethonium Succinoyl Hydrolyzed Pea Protein, Lactobacillus Ferment, Xanthan Gum, Sodium Polyacryloyldimethyl Taurate, Silica, Sodium Hydroxide, Sodium Polynaphthalenesulfonate

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN.

* Please review the disclaimer below.