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FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
6% Salicylic Acid Cream contains 6% salicylic acid USP with a vehicle containing Ammonium Lactate, Cetyl Alcohol, Cholesterol, Dimethicone, Disodium EDTA, Distearyldimonium Chloride, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, PEG-150 Stearate, Phenoxyethanol, Polysorbate 80, Propylparaben, Purified Water, Stearyl Alcohol and Triethanolamine.
6% Salicylic Acid Lotion contains 6% w/w salicylic acid USP in a vehicle consisting of Ammonium Lactate, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Disopropyl Adipate, Dimethicone, Disodium EDTA, Distearyldimonium Chloride, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, PEG-150 Stearate, Phenoxyethanol, Polysorbate 80, Propylparaben, Purified Water and Triethanolamine. Salicylic acid is the 2-hydroxy derivative of benzoic acid
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.)
Salicylic Acid Indications and Usage
For Dermatologic Use: 6% Salicylic Acid 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: 6% Salicylic Acid 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.