Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Perrigo New York Inc
SALICYLIC ACID
SALICYLIC ACID 6 mg in 100 mL
PRESCRIPTION DRUG
unapproved drug other
SALICYLIC ACID- SALICYLIC ACID SHAMPOO PERRIGO NEW YORK INC _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 SHAMPOO, 6% (W/W) RX ONLY FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. DESCRIPTION Salicylic Acid Shampoo, 6% (w/w) contains salicylic acid USP, in a vehicle consisting of acrylates copolymer, behentrimonium chloride, cocamidopropyl betaine, disodium EDTA, glycerin, isopropyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, quaternium 26, sodium laureth sulfate, and trolamine. Salicylic acid is the 2-hydroxy derivative of benzoic acid with 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 intercellular 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 extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space (see PRECAUTIONS). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic Aqra d-dokument sħiħ