Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Exact-Rx, Inc.
SALICYLIC ACID
SALICYLIC ACID 60 mg in 1 g
PRESCRIPTION DRUG
For Dermatologic Use: SA 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: SA 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. SA 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. SA 6% should not be used in children under 2 years of age.
Salicyclic Acid 6% Cream Kit, NDC 42808-0399-16, contains a 16 oz. (454 g) jar of Salicylic Acid Cream and a 12 fl. oz. (355 mL) bottle of Hydrating Cleanser. Salicyclic Acid 6% Lotion Kit, NDC 42808-0399-08, contains an 8 oz. (277 g) bottle of Salicylic Acid Lotion and a 12 fl. oz. and a 12 fl. oz. (355 mL) Hydrating Cleanser.. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing. Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 00-0399-16-205-00/00-399-08-205-00 Iss:8/11
unapproved drug other
SALICYLIC ACID- SALICYLIC ACID EXACT-RX, 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 6% CREAM KIT SALICYLIC ACID 6% LOTION KIT RX ONLY FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. DESCRIPTION SA 6% CREAM contains 6% salicylic acid USP incorporated into a specially formulated oil and water emulsion (0IW)™™ 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, glycerine, cetearyl alcohol (and) PEG-3, distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol and cetearyl alcohol. SA 6% LOTION contains 6% w/w salicylic acid USP incorporated into a specially formulated oil and water emulsion (0IW)™ 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. Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: This (0IW)™ formulation has been shown to provide gradual and prolonged release of the active ingredient into the skin. 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 ap Perskaitykite visą dokumentą