PSORIASIN DEEP MOISTURIZING- coal tar ointment 
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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Drug Facts

Active ingredient

Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)

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 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

Ethanol, light mineral oil, petrolatum, polysorbate 80.

Questions?

1-800-792-2582

Psoriasin Ointment Insert

PSORIASIN DEEP MOISTURIZING OINTMENT

DERMATOLOGIST RECOMMENDED

Psoriasin Deep Moisturizing Ointment treats psoriasis symptoms where they start, to help stop the itching, flaking, redness and related discomforts associated with psoriasis. Formulated in a soothing ointment base, it penetrates the skin while the rich moisturizing ingredients help create a barrier to lock in moisture for hours - so it's great for overnight use. Use Psoriasin Deep Moisturizing Ointment to relieve symptoms of psoriasis and to help restore your skin to a more natural looking appearance.

How Coal Tar Works

The coal tar in Psoriasin Deep Moisturizing Ointment 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 excessive skin cell production means it can help reduce the itching, scaling and redness of psoriasis. With regular use as directed, Psoriasin Deep Moisturizing Ointment 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 andrenal 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 Deep Moisturizing Ointment. 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 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 or 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 your 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 Deep Moisturizing Ointment 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.

PsoriasinOintmentPDP

PSORIASIN  DEEP MOISTURIZING
coal tar ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-652-421 in 1 CARTON03/10/2017
1NDC:52389-652-01119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:52389-652-02119 g in 1 TUBE; Type 0: Not a Combination Product06/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/10/2017
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 9/2018
Document Id: 7663713a-a54c-4da1-e053-2a91aa0a15ae
Set id: a8420c3b-e045-479a-8cc7-6e6f327bb118
Version: 2
Effective Time: 20180921
 
Alva-Amco Pharmacal Companies, Inc.