NDC 73597-008 Royal Dandruff

Pyrithione Zinc

NDC Product Code 73597-008

NDC 73597-008-10

Package Description: 273.06 g in 1 BOTTLE

NDC Product Information

Royal Dandruff with NDC 73597-008 is a a human over the counter drug product labeled by Mission Series Inc. Dba Prestige Beauty Care. The generic name of Royal Dandruff is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Mission Series Inc. Dba Prestige Beauty Care

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.

Royal 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 1 g/100g

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.

  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
  • ZINC CARBONATE (UNII: EQR32Y7H0M)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • MENTHOL (UNII: L7T10EIP3A)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • WATER (UNII: 059QF0KO0R)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Mission Series Inc. Dba Prestige Beauty Care
Labeler Code: 73597
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: 05-07-2020 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.

Royal Dandruff Product Label Images

Royal 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

Active Ingredient - Pyrithione Zinc 1%

Purpose

Purpose - Anti-dandruff

Use

Use - helps purify scalp and hair to restore natural shine.

Warnings

Warnings - For external use only.

Warnings - For external use only.

When Using This Product

When using this product- do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use

Stop use and ask a doctor if- condition worsens or does not improve after regular use as directed.

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

Directions- shake well. Wet hair. Massage onto scalp. Rinse. Repeat if desired.- for best results use at least twice a week or as directed by a doctor.- for maximum dandruff control, use every time you shampoo.

Inactive Ingredients

Inactive Ingredients - Water, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocoamide MEA, Zinc Carbonate, Glycol Distearate, Dimethicone, Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Magnesium Sulfate, Sodium Benzoate, Magnesium Carbonate Hydroxide, Ammonium Laureth Sulfate, Benzyl Alcohol, Sodium Chloride, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Xylenesulfonate, Menthol, Yellow 5, Blue 1.

Distributed By

Distributed By:PRESTIGE BEAUTY CARE1585 West Mission Blvd.Pomona, CA 91766Made in China

* Please review the disclaimer below.