Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Trinity Pharmaceuticals, LLC
TOPICAL
PRESCRIPTION DRUG
For Dermatologic Use: Salicylic Acid 6% 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). For Podiatric Use: Salicylic Acid 6% is a topical aid in the removal of excessive keratin on 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% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% should not be used in children under 2 years of age.
Salicylic Acid 6% Cream is available in 16 oz (454 g) bottles, NDC 54295-302-21 Salicylic Acid 6% Lotion is available in 16 fl. oz (473 mL) bottles, NDC 54295-303-21 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F), however such exposure should be minimized. Protect from freezing. Manufactured for: Trinity Pharmaceuticals, LLC 900 C Frederick Pike, Littlestown, PA 17340 TrinityPharmallc.com
unapproved drug other
SALICYLIC ACID- SALICYLIC ACID LOTION TRINITY PHARMACEUTICALS, 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% CREAM SALICYLIC ACID 6% LOTION RX ONLY FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. INGREDIENTS SALICYLIC ACID 6% CREAM contains 6% salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of trolamine, purified water, methyl paraben, propyl paraben, phenoxyethanol, PEG 100 stearate, mineral oil, glyceryl stearate SE, dimethicone 350, ammonium lactate, disodium EDTA, glycerin, cetearyl alcohol (and) PEG-3, distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol and cetearyl alcohol. SALICYLIC ACID 6% LOTION contains 6% w/w salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of trolamine, purified water, methyl paraben, propyl paraben, PEG 100 stearate, cetyl alcohol, mineral oil, glyceryl stearate SE, dimethicone 350, ammonium lactate, disodium EDTA, glycerine, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60. DESCRIPTION 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 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 Leggi il documento completo