NDC 72249-100 Dandrene

Pyrithione Zinc

NDC Product Code 72249-100

NDC 72249-100-01

Package Description: 1 BOTTLE in 1 BOX > 205 g in 1 BOTTLE

NDC Product Information

Dandrene with NDC 72249-100 is a a human over the counter drug product labeled by Divine Skin Laboratories S.a. De C.v.. The generic name of Dandrene is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Divine Skin Laboratories S.a. De C.v.

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.

Dandrene 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 20 mg/g

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)
  • SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
  • DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)
  • LUPINUS ALBUS SEED (UNII: 24GB753W3B)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POMEGRANATE FRUIT RIND (UNII: RS999V57DU)
  • ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
  • SHIKIMIC ACID (UNII: 29MS2WI2NU)
  • TIOXOLONE (UNII: S0FAJ1R9CD)
  • EMU OIL (UNII: 344821WD61)

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: Divine Skin Laboratories S.a. De C.v.
Labeler Code: 72249
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: 05-01-2018 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 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.

Dandrene Product Label Images

Dandrene 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% w/w

​Purpose

Anti-dandruff

​Uses

Relieves and helps prevent recurrence of scalp itch, irritation, redness, flaking and scaling associated with dandruff.

​Warnings

​For external use only.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 out of reach of children.  ​If swallowed, get medical help or contact Poison Control Center right away.

​Directions

Apply shampoo to wet hair and scalp with a gentle massage, leave in for 2-3 minutes, rinse.For best results use at least 2 times per week or as directed by a doctor.For maximum benefit use 4-5 times a week along with Dandrene Anti-Dandruff Conditioner.

​Inactive Ingredients

Water, Sodium Lauryl Sulfoacetate, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Triethanolamine, Glycolic Acid, Cocamide MEA, Glyceryl Stearate, PEG-150 Distearate, Magnesium Aluminum Silicate, Sodium Citrate, Hexamidine Diisethionate, Hydrolyzed Lupine Protein, Caprylyl Glycol, Phenoxyethanol, Butylene Glycol, Pomegranage Peel (Punica Granutum) Extract, Rosemary (Rosmarinus Officinalis) Leaf Extract, Shikimic Acid, Tioxolone, Emu Oil, Fragrance, Blue 1

* Please review the disclaimer below.