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selenium sulfide shampoo
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----------Selenium Sulfide 2.25% Shampoo
River’s Edge Selenium Sulfide 2.25% Shampoo contains Selenium Sulfide 2.25%, Ammonium Lauryl Sulfate, Caprylic/Capric Triglyceride, Chromium Oxide Green, Citric Acid, Cocamidopropyl Betaine, D and C Yellow No. 8, Diazolidinyl Urea, Edetate Disodium, FD and C Red No. 40, Fragrance, Hydroxypropyl Methylcellulose, Magnesium Aluminum Silicate, Methylparaben, Panthenol, PPG-2 Hydroxyethyl Coco/Isostearamide, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Titanium Dioxide, Tocopheryl Acetate, Urea and Zinc Pyrithione.
Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.
INDICATIONS AND USAGE:
A liquid antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.
Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.
For external use only. Not for ophthalmic use. DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS. If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. These areas should be thoroughly rinsed with water after application.
This medication is to be used as directed by a physician. Not to be used when inflammation or exudation is present as increased absorption may occur.
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.
USE IN PREGNANCY:
CATEGORY C. Animal reproduction studies have not been conducted with River’s Edge Selenium Sulfide 2.25% Shampoo. It is also not known whether Selenium Sulfide 2.25% Shampoo can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, Selenium Sulfide 2.25% Shampoo should not be used by pregnant women.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when River’s Edge Selenium Sulfide 2.25% Shampoo is administered to nursing women.
In decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
No documented reports of serious toxicity in humans resulting from acute ingestion of River’s Edge Selenium Sulfide 2.25% Shampoo. However, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.
DOSAGE AND ADMINISTRATION:
For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Should not be applied more frequently than necessary to maintain control.
For tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days or as directed by a physician.
River’s Edge Selenium Sulfide 2.25% Shampoo is supplied in a 180 mL bottle, NDC 68032-127-18.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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