NDC 51545-220 Denorex Therapeutic

Coal Tar And Menthol

NDC Product Code 51545-220

NDC 51545-220-12

Package Description: 296 mL in 1 BOTTLE

NDC Product Information

Denorex Therapeutic with NDC 51545-220 is a a human over the counter drug product labeled by Ultimark Products Llc. The generic name of Denorex Therapeutic is coal tar and menthol. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Ultimark Products Llc

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.

Denorex Therapeutic 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.

  • COAL TAR .018 g/mL
  • MENTHOL .015 g/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • CHLOROXYLENOL (UNII: 0F32U78V2Q)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: V176GWC2SR)
  • TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ultimark Products Llc
Labeler Code: 51545
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: 09-09-2019 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: 12-31-2020 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.

Denorex Therapeutic 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 Ingredients:

Coal tar solution 9.0% v/v (equivalent to 1.8% coal tar)

Menthol 1.5%

Purpose:

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Controls scalp itch

Uses:

  • Relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
  • Extra relief of itching due to dandruff

Warnings:

For external use only

Do Not Use:

  • For prolonged periods without consulting a doctor
  • This product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

Ask A Doctor Before Use If You Have

Condition covers a large area of the body.

When Using This Product:

  • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
  • Use caution in exposing skin to sunlight after applying. It may increase your tendency to sunburn for up to 24 hours after application.

Stop Use And Ask A Doctor If:

Condition worsens or does not improve after regular use of this product as directed.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Shake well
  • Apply to wet hair
  • Gently massage into hair and scalp to work up a lather
  • Rinse thoroughly and repeat
  • For best results, use at least twice a week or as directed by a doctor

Inactive Ingredients

Alcohol 7.3%, avocado oil, chloroxylenol, citric acid, dimethicone copolyol, FD&C red #40, fragrance, glycol distearate, hydroxypropyl methylcellulose, lauramide DEA, panthenol (provitamin B5), PEG-30 lanolin, quaternium-80, ricinoleamidopropyl ethyldimonium ethosulfate, TEA lauryl sulfate, vitamin E acetate, water

Questions?

1-800-443-4908 or


www.denoraxshampoo.com

Warning:

This product contains a chemical known to the State of California to cause cancer.

* Please review the disclaimer below.