NDC 52389-670 Psoriasin In-shower Treatment

Coal Tar

NDC Product Code 52389-670

NDC 52389-670-05

Package Description: 140 g in 1 TUBE

NDC Product Information

Psoriasin In-shower Treatment with NDC 52389-670 is a a human over the counter drug product labeled by Alva-amco Pharmacal Companies, Llc. The generic name of Psoriasin In-shower Treatment is coal tar. The product's dosage form is lotion/shampoo and is administered via topical form.

Labeler Name: Alva-amco Pharmacal Companies, Llc

Dosage Form: Lotion/shampoo - A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it 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.

Psoriasin In-shower Treatment 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 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETEARYL BEHENATE (UNII: 7ARI9LTH0U)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)
  • CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MYRISTYL ALCOHOL (UNII: V42034O9PU)
  • OATMEAL (UNII: 8PI54V663Y)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • WHITE PETROLATUM (UNII: B6E5W8RQJ4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SHEANUT OIL (UNII: O88E196QRF)

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: Alva-amco Pharmacal Companies, Llc
Labeler Code: 52389
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: 03-03-2021 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.

Psoriasin In-shower Treatment Product Label Images

Psoriasin In-shower Treatment 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 2% (from Coal Tar Topical Solution, USP 20%)

Purpose

Psoriasis / Seborrheic Dermatitis Treatment

Uses

For the relief of symptoms of psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irriation of the skin. Helps prevent recurrence.

Warnings

For external use only.

Ask A Doctor Before Use

  • For prolonged periodsif condition covers a large area of the bodywith other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs

When Using This Product

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

Stop Use And Ask A Doctor If

  • Condition worsenscondition does not improve after regular use of this product as directed.

Use Caution

In exposing skin to sunlight after applying this product, as it may increase your tendency to sunburn for up to 24 hours after application.Warning: This product contains chemicals known to the State of California to cause cancer.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control cente right away.

Directions

After cleansing, apply Psoriasin In-Shower Treatment to affected areas on body and scalp. Avoid applying to bottom of feet. Leave on for at least 2 minutes, then rinse off and gently towel dry. For best results, use at least twice a week or as directed by a doctor. The active ingredient, coal tar, in Psoriasin may affect very light hair color; test first on a few strands of hair before broader application to areas where light-colored hair is present. For use by normally healthy adults only; persons under 18 years of age or those with highly sensitive or allergic skin should use only as idrected by a doctor.

Other Information

You may report serious side effects to the phone number provided under
Questions? below.

Inactive Ingredients

Aloe vera gel, capylic/capric triglycerides, cetearyl alcohol, citric acid anhydrous, Dead Sea salts, ethanol, glycerin, glyceryl stearate SE, lavender oil, myristyl alcohol, oatmeal extract, olive oil, PEG-100 stearate, petrolatum, phenoxyethanol, polysorbate 80, shea oil, stearyl alcohol, sweet almond oil, water.

Questions?

1-800-792-2582

* Please review the disclaimer below.