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salicylic acid gel
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----------6% Salicylic Acid Gel
INDICATIONS AND USAGE
For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.
DOSAGE AND ADMINISTRATION
Apply 6% Salicylic Acid Gel thoroughly to the affected area and cover the area at night. The skin should be soaked in water for at least five minutes prior to application, preferably. The medication is washed off in the morning. In those areas where occlusion is difficult or impossible, more frequent application may be necessary. Once clearing is apparent, occasional use of 6% Salicylic Acid Gel will usually help maintain the remission. Hands should be rinsed thoroughly after application, unless hands are being treated.
6% Salicylic Acid Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. 6% Salicylic Acid Gel should not be used in children under 2 years of age.
WARNINGS AND PRECAUTIONS
Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of 6% Salicylic Acid Gel should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye’s Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.
Excessive erythema and scaling conceivably could result from use on open skin lesions.
Salicylates compete with the binding of several drugs and can modify the action of these drugs. Due to the competition of salicylate with other drugs for binding to serum albumin, the following drug interactions may occur:
USE IN SPECIFIC POPULATIONS
In cases of suspected salicylate toxicity, the use of 6% Salicylic Acid Gel should be discontinued, and the patient should be monitored closely for signs of: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. Call your local poison control center and/or your doctor if overdosage is suspected.
6% Salicylic Acid Gel is a gel for topical administration containing 6% Salicylic Acid in a vehicle composed of Disodium EDTA, Hydroxyethyl Cellulose, Propylene Glycol, Purified Water, SD Alcohol 40-2.
Salicylic acid is a keratolytic that has been shown to produce desquamation of the stratum corneum of the skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The exact mechanism of action is unknown, however, it has been attributed to the dissolution of intercellular adhesions . While topical administration can lead to systemic absorption, systemic toxic reactions are usually associated with much higher serum concentrations (30 to 40 mg/100 ml). Occlusion can lead to higher systemic absorption.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
No data is available concerning potential carcinogenic or reproductive effects of 6% Salicylic Acid Gel. It has been shown to lack mutagenic potential in the Ames Salmonella test.
40 g tube of translucent gel, NDC 68032-227-41.
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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