PSORIASIN GEL- coal tar topical gel gel 
Alva-Amco Pharmacal Companies, Inc.

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.

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Psoriasin Gel

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

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

Stop use and ask a doctor if

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 center right away.

Directions

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

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:

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.

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:

WWW.PSORIASIN.COM

Package label for Psoriasin Gel

PSORIASIN GEL 
coal tar topical gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-166
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:52389-166-2121.25 g in 1 TUBE; Type 0: Not a Combination Product03/01/200106/01/2013
2NDC:52389-166-011 in 1 CARTON03/15/2013
2NDC:52389-166-2828.35 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:52389-166-562 in 1 CARTON10/01/2013
3NDC:52389-166-2828.35 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:52389-166-422 in 1 BOX01/02/201306/01/2013
421.25 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:52389-166-432 in 1 BOX06/01/2020
521.25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H02/18/1996
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 11/2020
Document Id: b3b4b87f-e47d-d0f3-e053-2a95a90ab8ee
Set id: a046878f-ffc7-417e-9145-5ccc176b4683
Version: 7
Effective Time: 20201109
 
Alva-Amco Pharmacal Companies, Inc.