Label: PSORIASIN - coal tar ointment
- NDC Code(s): 52389-178-04
- Packager: Alva-Amco Pharmacal Companies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 7, 2010
If you are a consumer or patient please visit this version.
- Active ingredient
Coal Tar 2% (from Coal Tar Topical Solution, USP)..............................Psoriasis/Seborrheic Dermatitis TreatmentClose
For external use only.Close
- 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 eyes. If contact occurs, rinse eyes thoroughly with water.Close
- Stop use and ask a doctor if
- condition worsens
- condition does not improve after regular use of this product as directed.
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.Close
- Read all package directions and warnings before using.
- 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.
- The active ingredient, coal tar, In Psoriasin Ointment 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 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
Serious side effects associated with the use of this product may be reported to the phone number provided below.Close
- Inactive ingredients
Ethanol, petrolatum, polysorbate 80.Close
- Psoriasin Ointment Insert
PSORIASIN OINTMENT Multi-Symptom Psoriasis Relief
- Stops Itching and Flaking
- No Unpleasant Lingering Odor
- Eliminates Redness and Scaling
- Won't Stain Skin
- Helps Prevent Recurrence
- Intensive Moisturizing
Coal tar in PSORIASIN 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.
A WORD ABOUT PSORIASIN OINTMENT
PSORIASIN Ointment offers complete multi-symptom relief in a deep moisturizing, "leave-on" topical treatment. PSORIASIN Ointment gets to work quickly to help eliminate the itching, flaking, redness, scaling and related discomforts often associated with psoriasis and seborrheic dermatitis. Formulated in a unique, soothing ointment base, PSORIASIN is easy to apply and absorbs while rich moisturizing ingredients protect skin and lock in moisture. With PSORIASIN Ointment, a little goes a long way. You can use PSORIASIN Ointment with confidence on skin during the day or night...plus it keeps working hour after hour to relieve all the symptoms of psoriasis and seborrheic dermatitis. The rich formula locks in moisture, and creates a barrier against irritants that may aggravate sensitive areas...keeps skin supple and flexible. With normal use as directed, PSORIASIN Ointment helps stop even the most intense itching and flaking; helps restore a healthier, more natural skin appearance...and helps prevent recurrence.
WHAT IS PSORIASIS AND SEBORRHEIC DERMATITIS?
PSORIASIS is a non-contagious skin disorder which afflicts millions of men and women of all ages. Normal skin cells multiply, mature and shed on a regular basis. In those afflicted with psoriasis, skin cells appear to multiply much faster than normal with excessive skin cells accumulating on the skin surface. In its most common form, these cells form scaly, reddish patches which are often unsightly, uncomfortable, and are frequently irritating, itchy and painful. While the exact causes of psoriasis are still unknown, it is reported that a susceptibility to psoriasis may be inherited...passed along from one generation to another genetically within families. First visible outbreaks of psoriasis may be prompted by a stress such as surgery, a major infection, or a minor skin injury such as a burn or cut. After the first outbreak, psoriasis flare-ups tend to come and go without any specific regularity or frequency. Symptoms appear to diminish during warm summer months and increase during cold winter months. Some studies have shown a relationship between psoriasis flare-ups and periods of emotional stress.
The number of flare-ups and their intensity may differ from case to case. Although there is no known cure for psoriasis, the active ingredient in PSORIASIN Ointment has been proven to help effectively relieve and control the symptoms of psoriasis, as well as prevent recurrences.
SEBORRHEIC DERMATITIS is a distinctly different condition, though sometimes confused with psoriasis. Seborrheic dermatitis is an inflammation affecting areas of the skin rich in sebaceous (oil producing) glands, commonly occurring on the hairy areas of the body, such as the trunk of the body, hairline, scalp, and face including the brows and especially around the nose. This troublesome skin disorder tends to be marked by skin cell proliferation and heightened sebaceous gland activity...skin cells shed and become scaly or itchy, red and irritated. Affected areas tend to display oily looking, yellowing scaly patches. People who tend toward oily skin are more likely to be affected. While seborrheic dermatitis and psoriasis are different disorders, troublesome symptoms of seborrheic dermatitis, such as intense itching and flaking (the appearance of dandruff) respond well (as do psoriasis symptoms) to the active ingredient in PSORIASIN Ointment. As such, these symptoms can be effectively relieved and controlled as well as recurrences prevented, with regular use of PSORIASIN Ointment as directed.
HOW DO YOU KNOW IF YOU HAVE PSORIASIS OR SEBORRHEIC DERMATITIS?
In its most common form, known as plaque psoriasis, the condition is characterized by sharply defined raised reddish areas of skin or patches typically covered with overlapping, rough, dry silvery scales, most often occurring on body extensions such as elbows and knees. Often times outbreaks are accompanied by itching and flaking at the affected site. In many cases, skin is cracked, irritated and burning. When soft tissue areas are affected, such as the palm of the hand, constant movement may cause skin to break and crack, causing pain and discomfort.
Seborrheic dermatitis tends to occur most often on the face and trunk. Both seborrheic dermatitis and psoriasis can and do affect the scalp. Seborrheic dermatitis tends to show up as thick, greasy, yellowish scales.
If you experience any type of unusual skin eruption(s) including those described here, contact your doctor to make the correct diagnosis and obtain professional advice. You may wish to show him/her PSORIASIN Ointment and discuss its use for relief and prevention.
HOW PSORIASIN OINTMENT CAN HELP; PRODUCT DESCRIPTION AND ACTION:
PSORIASIN Ointment is a convenient and highly effective treatment for relief of symptoms of psoriasis and seborrheic dermatitis affecting the skin. PSORIASIN Ointment is a "leave-on", intensive moisturizing treatment application which allows the active ingredient to remain at work hour after hour...to achieve optimal effective relief. PSORIASIN Ointment is formulated in a soothing and rich moisturizing ointment base.
After application, the active ingredient in PSORIASIN Ointment starts to work immediately to help relieve suffering four ways:
- PSORIASIN Ointment helps calm and normalize skin affected by psoriasis flare-ups.
- PSORIASIN Ointment helps remove scaling and roughness.
- PSORIASIN Ointment helps relieve related itching, irritation and discomfort...helps promote healing.
- PSORIASIN Ointment helps lock in skin's own moisture to help skin feel more comfortable.
With regular use, PSORIASIN Ointment can help prevent recurrence of symptoms of psoriasis and seborrheic dermatitis. Should symptoms recur, don't hesitate to again use PSORIASIN Ointment for prompt relief and to help restore affected areas to their healthier looking appearance.
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, or 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 or 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.
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 using. Use only as directed. Apply (gently massage in) a small amount of PSORIASIN Ointment to affected areas. Apply one to four times daily or as directed by a doctor. Apply to thoroughly dry skin. 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 ofage or those with highly sensitive or allergic skin should use only as directed by a doctor. The active ingredient, coal tar, in PSORIASIN Ointment 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.
OTHER INFORMATION: You may report serious side effects to the phone number provided under Questions? below.
ACTIVE INGREDIENT: Coal Tar 2% (from Coal Tar Topical Solution, USP).
INACTIVE INGREDIENTS: Ethanol, petrolatum, and polysorbate 80.
HOW SUPPLIED: As a topical ointment: net weight 4 oz. (113g) in a jar.
Keep tightly closed when not in use. Store away from excessive heat and cold.Close
- INGREDIENTS AND APPEARANCE
coal tar ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-178 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC) Coal Tar 20 mg in 1 g Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Alcohol (UNII: 3K9958V90M) Polysorbate 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-178-04 113 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358 06/01/2004 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)