NDC 73503-005 Psodex Psoriasis Cream Standard Therapy

Coal Tar

NDC Product Code 73503-005

NDC 73503-005-01

Package Description: 1 BOTTLE in 1 BOX > 100 mL in 1 BOTTLE

NDC Product Information

Psodex Psoriasis Cream Standard Therapy with NDC 73503-005 is a a human over the counter drug product labeled by Psodex Usa Inc.. The generic name of Psodex Psoriasis Cream Standard Therapy is coal tar. The product's dosage form is cream and is administered via topical form.

Labeler Name: Psodex Usa Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Psodex Psoriasis Cream Standard Therapy 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 5 mg/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.

  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BORAGE SEED OIL (UNII: F8XAG1755S)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • TURMERIC (UNII: 856YO1Z64F)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • GENISTEIN (UNII: DH2M523P0H)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • PUMPKIN SEED OIL (UNII: 6E5QR5USSP)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NIACIN (UNII: 2679MF687A)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • ZINC ACETATE (UNII: FM5526K07A)

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: Psodex Usa Inc.
Labeler Code: 73503
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: 03-01-2021 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.

Psodex Psoriasis Cream Standard Therapy Product Label Images

Psodex Psoriasis Cream Standard Therapy 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

Coal Tar 0.5%

Purpose

Psoriasis cream

Use

Controls the symptoms of psoriasis

Warnings

For external use only

When Using This Product

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

Do Not Use

  • For prolonged periods of time without consulting a doctor.In or around the rectum or in the genital area or groin except on the advice of a doctor.With other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to by a doctor.

Ask A Doctor Before Use If

Condition covers a large area of the body

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

Apply to affected areas one to four times daily or as directed by a doctor.

Other Information

Store at controlled room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, Borage Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic Capric Triglyceride, Caprylyl Glycol, Centella Asiatica Whole Extract, Cetearyl Alcohol, Cetearyl Olivate, Curcuma Longa Extract, D -Camphor Natural, D-Panthenol, Distilled Water, Ethylhexylglycerin, Frankincense Oil, Fumaria Officina is Extract, Genistein, Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Piperita Leaf Extract, Pumpkin Seed Oil, Rosemary Leaf Oil, Salicylic Acid, Sorbitan Olivate, Stearic Acid, Tea Tree Leaf Oil, Vegetable Glycerin, Vitamin B3, Vitamin E, Zinc Acetate.

* Please review the disclaimer below.