PSORIASIN DEEP MOISTURIZING- coal tar ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)
Available from:
Alva-Amco Pharmacal Companies, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Psoriasis/Seborrheic Dermatitis Treatment 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. - 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. - 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.
Authorization status:
OTC monograph final
Authorization number:
52389-752-02, 52389-752-42

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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Psoriasin Ointment

Active ingredient

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

Purpos e

Psoriasis/Seborrheic Dermatitis Treatment

Us es

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 this product avoid contact with 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. 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 to affected areas.

Apply one to four times daily or as directed by a doctor.

Apply to thoroughly dry skin.

May be difficult to wash out of hair; consider this before using on scalp or hairline areas.

The active ingredient, coal tar, in Psoriasin Deep Moisturizing Ointment may affect very light hair

color; test first on a small patch of hair before broader application to areas where light colored hair

is present.

Wash affected areas 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

Ethanol, petrolatum, polysorbate 80.

Ques tions ?

1-800-792-2582

Psoriasin Ointment Insert

PSORIASIN DEEP MOISTURIZING OINTMENT

DERMATOLOGIST RECOMMENDED

Stops Psoriasis itching, scaling, redness

Can complement topical steroids

Visible results in just days

Helps prevent recurrence

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:

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 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:

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.

PSORIASIN DEEP MOISTURIZING

coal tar ointment

Product Information

Alva-Amco Pharmacal Companies, Inc.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5238 9 -752

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CO AL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)

COAL TAR

20 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5238 9 -752-42

1 in 1 CARTON

0 6 /21/20 19

1

119 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:5238 9 -752-0 2

119 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /21/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 6 /21/20 19

Labeler -

Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 7/2019

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