NDC 51545-210 Denorex Extra Strength

Salicylic Acid

NDC Product Code 51545-210

NDC 51545-210-12

Package Description: 296 mL in 1 BOTTLE

NDC Product Information

Denorex Extra Strength with NDC 51545-210 is a a human over the counter drug product labeled by Ultimark Products Llc. The generic name of Denorex Extra Strength is salicylic acid. 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 Extra Strength 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.

  • SALICYLIC ACID .03 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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • MENTHOL (UNII: L7T10EIP3A)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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.

Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Denorex Extra Strength 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:

Salicylic acid 3%

Purpose

Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Uses

  • Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
  • Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis

Warnings

For external use only.

Ask A Doctor Before Use If You Have

A condition that covers a large area of the body.

When Using This Product

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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 weekly or as directed by a doctor

Other Information

Store at 20º-25º C (68º – 77º F)

Inactive Ingredients

Cocamidopropyl betaine, D&C Red No. 33, D&C Yellow No. 10, dimethicone PEG-8 meadowfoamate, FD&C Blue No. 1, FD&C Yellow No. 6, fragrance, glycol distearate, menthol, panthenol, polyquaternium-10, PPG-2 hydroxyethyl cocamide, propylene glycol, sodium C14-C16 olefin sulfonate, sodium citrate, vitamin E acetate, water

Questions?

1-800-220-0151www.denorex.net

* Please review the disclaimer below.