Psoriasin Gel

Coal Tar


Denison Pharmaceuticals Inc.
Human Otc Drug
NDC 0295-6602
Psoriasin Gel also known as Coal Tar is a human otc drug labeled by 'Denison Pharmaceuticals Inc.'. National Drug Code (NDC) number for Psoriasin Gel is 0295-6602. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Psoriasin Gel drug includes Coal Tar - 12.5 mg/g . The currest status of Psoriasin Gel drug is Active.

Drug Information:

Drug NDC: 0295-6602
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Psoriasin Gel
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Coal Tar
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Denison Pharmaceuticals Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:COAL TAR - 12.5 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 18 Jan, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 08 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part358H
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Denison Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:415978
1043397
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0072959660284
UPC stands for Universal Product Code.
UNII:R533ESO2EC
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0295-6602-0628.35 g in 1 TUBE (0295-6602-06)18 Jan, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose psoriasis/seborrheic dermatitis treatment

Product Elements:

Psoriasin gel coal tar aloe vera leaf alcohol hydroxypropyl cellulose (type m) isopropyl alcohol polyethylene glycol 400 polysorbate 80 water alpha-tocopherol acetate coal tar coal tar

Indications and Usage:

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:

Warnings for external use only.

When Using:

When using this product avoid contact with the eyes. if contact occurs, rinse eyes thoroughly with water.

Dosage and Administration:

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.

Stop Use:

Stop use and ask a doctor if condition worsens condition 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.

Information for Patients:

Other information you may report serious side effects to the phone number provided under questions? below.

Spl Patient Package Insert:

Package insert psoriasin daytime relief vanishing gel dermatologist recommended stops psoriasis itching, scaling, redness can complement topical steroids dries quickly, low odor visible results in just days helps prevent recurrence psoriasin 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 works the 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 steroids topical 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 control due 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 tips in addition to psoriasis treatments recommended by a doctor, you can help reduce psoriasis symptoms by using self-care approaches, including: keep skin moisturized using 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 care too 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 stress stress 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 massage excercise regularly get enough sleep be smart about sunlight the 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 plan applying 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

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Further Questions:

Questions? 1-800-792-2582


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* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.