NDC 72698-811 Art Of Sport Anti Dandruff Compete

Pyrithione Zinc

NDC Product Code 72698-811

NDC 72698-811-11

Package Description: 400 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Art Of Sport Anti Dandruff Compete with NDC 72698-811 is a a human over the counter drug product labeled by Aos Group, Inc.. The generic name of Art Of Sport Anti Dandruff Compete is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

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.

Art Of Sport Anti Dandruff Compete 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.


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
  • PEG-16 MACADAMIA GLYCERIDES (UNII: 2OTC93KMHU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SORBIC ACID (UNII: X045WJ989B)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • LAURYL LACTATE (UNII: G5SU0BFK7O)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • ALCOHOL (UNII: 3K9958V90M)

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: Aos Group, Inc.
Labeler Code: 72698
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: 12-12-2019 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: 12-31-2022 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.

Art Of Sport Anti Dandruff Compete 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

Active Ingredients
Pyrithione Zinc 1%

Otc - Purpose

Purpose
Anti-dandruff

Indications & Usage

Uses help prevent recurrence of flaking and itching associated with dandruff.

Warnings

Warnings
For external use only.

Otc - When Using

When using this product * avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Otc - Stop Use

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 this and all drugs out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Dosage & Administration

Directions * for best results use at least twice a week or as directed by a doctor * for maximum dandruff control, use every time you shampoo * shake before use * wet hair, massage into scalp, rinse, repeat if desired.

Inactive Ingredient

Inactive ingredients: Water, Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Decyl Glucoside, Fragrance, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hamamelis Virginiana (Witch Hazel) Leaf Water, Cellulose Gum, Lauryl Lactate, Polyquaternium-10, PEG-16 Macadamia Glycerides, Sodium Polynaphthalenesulfonate, Alcohol, Propylene Glycol, Phenoxyethanol, Sorbic Acid, Benzoic Acid, Citric Acid

Otc - Questions

Questions? [email protected]

* Please review the disclaimer below.