País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
PruGen, Inc.
SALICYLIC ACID
SALICYLIC ACID 27.24 g in 1 g
TOPICAL
PRESCRIPTION DRUG
Salicylic Acid 6% (w/w) Cream 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% (w/w) Cream 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) Cream should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% (w/w) Cream should not be used in children under 2 years of age.
Salicylic Acid 6% (w/w) Cream Kit includes a 16 oz. (454 g) jar with Salicylic Acid 6% (w/w) Cream (NDC 42546-270-16) as well as a complimentary 12 fl. oz. PruDrate Hydrating Cleanser. 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. Do not freeze.
unapproved drug other
SALICYLIC ACID- SALICYLIC ACID PRUGEN, 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 RX ONLY FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. DESCRIPTION Salicylic Acid 6% (w/w) Cream contains salicylic acid, USP 6% in a cream base composed of ammonium lactate, cetearyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, dimethicone 350, disodium EDTA, glycerine, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water and trolamine. Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: This 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 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 sp Leia o documento completo