Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)
PruGen LLC
salicylic acid
salicylic acid 6 mg in 100 mL
TOPICAL
PRESCRIPTION DRUG
Salicylic Acid 6% (w/w) Shampoo is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). Salicylic Acid 6% (w/w) Shampoo is a topical aid in the removal of excessive keratin on the dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares. Salicylic Acid 6% (w/w) Shampoo should not be used in any Patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% (w/w) Shampoo should not be used in children under 2 years of age.
Salicylic Acid 6% (w/w) Shampoo is available in 177mL plastic bottles (NDC 42546-279-06). Store at controlled room temperature 20°-25°C (68°-77°F). Do not freeze.
unapproved drug other
SALICYLIC ACID 6 PERCENT- SALICYLIC ACID SHAMPOO PRUGEN LLC _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._ ---------- SALICYLIC ACID 6% (W/W) SHAMPOO RX ONLY FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC,ORAL OR INTRAVAGINAL USE. DESCRIPTION SHAMPOO contains 6% w/w salicylic acid USP in a vehicle composed of purified water, disodium laureth sulfosuccinate, cocamidopropyl betaine, hexylene glycol, linoleamidpropyl PG-dimonium chloride phosphate, polyquaternium-22, propylene glycol, sodium C14-16 olefin sulfonate, sodium citrate, sodium lauryl sarcosinate, tetrasodium EDTA, tocopherol acetate and fragrance. Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: CLINICAL PHARMACOLOGY Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to a dissolution of inter cellular cement substance. In a study of the percutaneous absorption of salicylic acid in a 6%salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extra cellular space, patients with a contracted extra cellular space due to dehydration or diuretics have a higher salicylate levels than those with a normal extra cellular space. (See PRECAUTIONS) The major metabolites identified in the urine after topical administration are salicyluric acid Đọc toàn bộ tài liệu