FDA Label for Psoriasin In-shower Treatment
View Indications, Usage & Precautions
Psoriasin In-shower Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Alva-amco Pharmacal Companies, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Coal Tar 2% (from Coal Tar Topical Solution, USP 20%)
Purpose
Psoriasis / Seborrheic Dermatitis Treatment
Uses
For the relief of symptoms of psoriasis and/or seborrheic dermatitis including itching, scaling, flaking, redness and irriation 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
- with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs
When Using This Product
avoid contact with the eyes. If contact occurs rinse 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 cente right away.
Directions
After cleansing, apply Psoriasin In-Shower Treatment to affected areas on body and scalp. Avoid applying to bottom of feet. Leave on for at least 2 minutes, then rinse off and gently towel dry. For best results, use at least twice a week or as directed by a doctor. The active ingredient, coal tar, in Psoriasin 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. 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 idrected by a doctor.
Other Information
You may report serious side effects to the phone number provided under Questions? below.
Inactive Ingredients
Aloe vera gel, capylic/capric triglycerides, cetearyl alcohol, citric acid anhydrous, Dead Sea salts, ethanol, glycerin, glyceryl stearate SE, lavender oil, myristyl alcohol, oatmeal extract, olive oil, PEG-100 stearate, petrolatum, phenoxyethanol, polysorbate 80, shea oil, stearyl alcohol, sweet almond oil, water.
Questions?
1-800-792-2582
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