Label: PSORIASIN THERAPEUTIC SHAMPOO AND BODY WASH- salicylic acid shampoo
Contains inactivated NDC Code(s)
NDC Code(s): 52389-171-06
- Packager: Alva-Amco Pharmacal Companies, 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.
Updated May 7, 2010
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- Active ingredient
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Read all package directions and warnings before use and use only as directed.
- For best results, use at least two times per week or as recommended by a doctor.
- Use on affected areas in place of regular soap or shampoo.
- Wet skin and/or scalp.
- Apply Psoriasin Therapeutic Shampoo and Body Wash and massage to form a rich lather.
- Leave lather on the scalp for two minutes.
- Rinse thoroughly.
- Repeat if necessary.
- 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
- Inactive ingredients
PSORIASIN Therapeutic Shampoo and Body Wash
3% Salicylic Acid
- Relieves the symptoms of psoriasis, seborrheic dermatitis and related discomforts
- Cleans, soothes and moisturizes
A WORD ABOUT PSORIASIN THERAPEUTIC SHAMPOO and BODY WASH
PSORIASIN Therapeutic Shampoo and Body Wash relieves the discomforts of psoriasis and seborrheic dermatitis. PSORIASIN Therapeutic Shampoo and Body Wash cleanses away scaling and flaking, relieves itching, redness and irritation on skin and scalp ... plus helps soothe and smooth skin and leave hair soft and manageable.
WHAT IS PSORIASIS AND SEBORRHEIC DERMATITIS?
PSORIASIS is a non-contagious skin disorder that 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, although 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 Therapeutic Shampoo and Body Wash 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 it is confused with psoriasis. Seborrheic dermatitis is an inflammation affecting areas of the skin rich in sebaceous (oil producing) glands commonly on the hairy areas of the body, such as the scalp. This troublesome skin disorder tends to be marked by skin cell proliferation and heightened sebaceous gland activity ... skin cells shed and become scaly, itchy, red and irritated. Affected areas tend to display oily looking, yellowish, scaly patches. People who tend toward oily skin are more likely to be affected. While seborrheic dermatitis and psoriasis are different disorders, highly visible symptoms of seborrheic dermatitis, such as intense itching and dandruff respond well (as well as psoriasis symptoms) to the active ingredient in PSORIASIN. These symptoms can be relieved and controlled, as well as recurrences prevented, with regular use of PSORIASIN Therapeutic Shampoo and Body Wash.
HOW DO YOU KNOW IF YOU HAVE PSORIASIS OR SEBORRHEIC DERMATITIS OF THE SCALP OR BODY?
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 scaling. Often times outbreaks are accompanied by itching and flaking at the affected site. In many cases skin is cracked, irritated and burning. Seborrheic dermatitis frequently affects the scalp and other areas rich in sebaceous (oil producing) glands. Seborrheic dermatitis tends to show up as thick, greasy, yellowish scales, accompanied by itching and irritation.
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 Therapeutic Shampoo and Body Wash and discuss its use for relief and prevention.
ACTIVE INGREDIENT: Salicylic Acid 3%
USES: For the relief of symptoms associated with psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irritation of the skin and scalp. Helps prevent recurrence.
WARNINGS: For external use only. Ask a doctor before use if condition covers a large area of the body. 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. 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 and use only as directed . • For best results, use at least two times per week or as recommended by a doctor .• Use on affected areas in place of regular soap or shampoo . • Wet skin and/or scalp . • Apply PSORIASIN Therapeutic Shampoo and Body Wash and massage to form a rich lather. • Leave lather on the scalp for two minutes. • Rinse thoroughly. • Repeat if necessary . • 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.
INACTIVE INGREDIENTS: Lauramidopropyl Betaine, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PSORIASIN THERAPEUTIC SHAMPOO AND BODY WASH
salicylic acid shampoo
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-171 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ) Salicylic acid 3 g in 100 g Inactive Ingredients Ingredient Name Strength Lauramidopropyl betaine (UNII: 23D6XVI233) Panthenol (UNII: WV9CM0O67Z) Lecithin, soybean (UNII: 1DI56QDM62) Water (UNII: 059QF0KO0R) Sodium chloride (UNII: 451W47IQ8X) Sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-171-06 185 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358 02/28/1999 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)