Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)
Rochester Pharmaceuticals
SELENIUM SULFIDE
SELENIUM SULFIDE 22.5 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
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. Safety and effectiveness in children have not been established.
Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles, NDC 49908-146-80. Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Rochester Pharmaceuticals Doylestown, PA 1-866-458-1772 www.RochesterPharm.com SSS-PI-915
unapproved drug other
SELENIUM SULFIDE- SELENIUM SULFIDE SHAMPOO ROCHESTER PHARMACEUTICALS _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- DESCRIPTION Rx Only Selenium Sulfide 2.25% Shampoo A liquid antiseborrehic, antifungal preparation for topical application. Each gram of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide greens, citric acid, cocamidopropyl betaine, D and C yellow No. 8, diazolidinyl urea, edetate disodium, FD and C red No. 40, fragrance, hydroxypropylmethylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propyleneglycol, propylparaben, purified water, sodium citrate, titanium dioxide, tocopheryl acetate, urea and zinc pyrithione. CLINICAL PHARMACOLOGY Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production. PHARMACOKINETICS The mechanism of action of topically applied selenium sulfide is not yet known. INDICATIONS & 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. CONTRAINDICATIONS Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients. WARNINGS 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. If accidental contact occurs, rinse thoroughly with water. PRECAUTIONS 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. CARCINOGENESIS Dermal application of 25% and 50% solutions of 2.5% Прочетете целия документ