Label: PSORIASIN GEL- coal tar gel

  • NDC Code(s): 0295-6602-06
  • Packager: Denison Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 18, 2019

If you are a consumer or patient please visit this version.

  • 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 periods
    • if condition covers a large area of the body
    • around the rectum or in the genital area or groin
    • with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.
  • 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 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.

  • 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 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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PSORIASIN GEL 
    coal tar gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-6602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-6602-0628.35 g in 1 TUBE; Type 0: Not a Combination Product01/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/18/2019
    Labeler - Denison Pharmaceuticals Inc. (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals Inc.001207208manufacture(0295-6602)