NDC 0295-6602 Psoriasin Gel

Coal Tar

NDC Product Code 0295-6602

NDC 0295-6602-06

Package Description: 28.35 g in 1 TUBE

NDC Product Information

Psoriasin Gel with NDC 0295-6602 is a a human over the counter drug product labeled by Denison Pharmaceuticals Inc.. The generic name of Psoriasin Gel is coal tar. The product's dosage form is gel and is administered via topical form.

Labeler Name: Denison Pharmaceuticals Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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 Gel 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 12.5 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALCOHOL (UNII: 3K9958V90M)
  • HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • WATER (UNII: 059QF0KO0R)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Denison Pharmaceuticals Inc.
Labeler Code: 0295
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: 01-18-2019 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.

Psoriasin Gel Product Label Images

Psoriasin Gel 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 1.25% (from coal tar topical solution, USP)

Purpose

Psoriasis/Seborrheic Dermatitis Treatment

Uses

For the relief of symptoms associated with psoriasis and/or seborrheic
dermatitis including itching, scaling, flaking, redness and irritation
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 bodyaround the rectum or in the genital area or groinwith other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.

Otc - When Using

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 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Directions

  • Read all package directions and warnings before use.Use only as directed.Apply (gently massage in) a small amount of Psoriasin Gel to affected areas.Apply one to four times daily or as directed by a doctor.Apply to thoroughly dry skin.The
  • Active ingredient, coal tar, in Psoriasin Gel 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.Wash affected area at least daily with mild soap and warm water and dry thoroughly.Intended 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 directed by a doctor.

Other Information

You may report serious side effects to the phone number provided under





Questions? below.

Inactive Ingredients

Aloe vera gel, ethanol, hydroxypropyl cellulose, isopropyl alcohol, polyethylene glycol, polysorbate 80, purified water and vitamin E acetate.

Questions?

1-800-792-2582

Package Insert

  • Psoriasin DAYTIME RELIEF VANISHING GELDERMATOLOGIST RECOMMENDED
  • Stops Psoriasis itching, scaling, rednessCan complement topical steroidsDries quickly, low odorVisible results in just daysHelps prevent recurrencePsoriasin Daytime Relief Vanishing Gel gets to work quickly to help stop the itching, flaking, redness and related discomforts associated with psoriasis. Formulated in a vanishing gel base with aloe and vitamin E, it applies easily, dries quickly and absorbs thoroughly, leaving no greasy appearance or lingering odor. Use
  • Psoriasin Daytime Relief Vanishing Gel with confidence to relieve symptoms of psoriasis and help restore you skin to a more natural looking appearance.
  • How Coal Tar WorksThe coal tar in
  • Psoriasin Daytime Relief Vanishing Gel slows down the excessive skin cell production that is the root cause of psoriasis symptoms. No other FDA compliant non-prescription drug ingredient works this way. Slowing excesive skin cell production means it can help reduce the itching, scaling and redness of psoriasis. With regular use as directed,
  • Psoriasin Daytime Relief Vanishing Gel can even help prevent recurrence of psoriasis symptoms. And coal tar can be used to complement topical steroid therapies.
  • The Role of Topical SteroidsTopical steroids - similar to the natural corticosteroid hormones produced by the adrenal glands - are a frequently used psoriasis symptom treatment. Topical steroids are used as anti-inflammatory agents to reduce the swelling and redness of lesions. Although topical steroids can produce rapid symptom relief, continuous use of them may cause potential side effects such as skin thinning.Topical Therapy Choices for Psoriasis Symptom ControlDue to the well documented side effects of topical steroids, some experts recommend using intermittent therapy (also called weekend or pulse therapy). This type of treatment involves applying a topical steroid for three consecutive days each week followed by four days of a coal tar medication like
  • Psoriasin Daytime Relief Vanishing Gel. Ask your doctor if this approach might be right for you.
  • PSORIASIS SELF-CARE TIPSIn addition to psoriasis treatments recommended by a doctor, you can help reduce psoriasis symptoms by using self-care approaches, including:Keep Skin MoisturizedUsing a moisturizer is an important part of self-care for psoriasis. Dry skin makes irritation and itching caused by psoriasis worse than it needs to be. A vicious cycle can result: dry skin can cause itching and scratching, leading to new psoriasis patches developing on the irritated skin. Dermatologists recommend ointments and heavy creams to lock water into the skin.Bathe with CareToo many baths and showers can dry your skin. Here are a few suggestions:Don't bathe or shower with hot water, which can irritate. Use lukewarm water instead.Don't dry off by rubbing with a towel. Pat yourself somewhat dry and then apply cream.Plain water can dry your skin. Adding salts, oil, or finely ground oatmeal to bath water can help to soothe your skin.Take fewer showers and baths. They can strip your skin of natural oils. Bathe every other day or every third day, especially during the winter months.Reduce StressStress can cause psoriasis to flare for the first time or aggravate existing psoriasis. Relaxation and stress reduction may help prevent stress from making your psoriasis symptoms worse.Engage in relaxation techniques, such as yoga, meditation, or massageExcercise regularlyGet enough sleepBe Smart About SunlightThe ultraviolet rays in sunlight slow the growth of skin cells, so getting moderate doses of sun is good. But make it brief and use sunscreen, because sunburn can trigger psoriasis flare-ups. Some medications can make your skin more sensitive to ultraviolet rays, so talk to your doctor first.Stick to the PlanApplying creams and ointments day after day can be inconvenient. But compliance is the key for topical therapies. Once you have a topical treatment regimen that's working for you, making it part of you daily routine can improve results. Also, topical therapies help you avoid the potential side effects of systemic treatments for psoriasis.The active ingredient in
  • Psoriasin Daytime Relief Vanishing Gel has been recognized to be safe and effective by an FDA Expert Advisory Panel when used as directed.
  • USE THE FAMILY OF PSORIASIN PRODUCTS TO BUILD YOUR PSORIASIS TREATMENT REGIMEN:PSORIASIN PROBLEM SKIN FORMULA CREAM Combines a low dose of coal tar with botanicals & Vitamin D3 in a soothing cream that won't irritate sensitive skin
  • PSORIASIN DEEP MOISTURIZING OINTMENT Delivers coal tar in a base that locks in moisture for hours to help restore your skin's appearance
  • PSORIASIN DAYTIME RELIEF VANISHING GEL Is a quick-drying, low-odor coal tar therapy
  • WWW.PSORIASIN.COM

* Please review the disclaimer below.

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