SALICYLIC ACID

Salicylic Acid 6% Gel is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. Each gram of Salicylic Acid 6% Gel contains salicylic acid 6% as the active ingredient, and the following inactive ingredients: hydroxypropylcellulose and propylene glycol. CHEMICAL STRUCTURE Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following chemical structure: STRUCTURE

For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.

The preferable method of use is to apply Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salicylic Acid 6% Gel will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application.

Salicylic Acid 6% Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% Gel should not be used in children under 2 years of age.

Excessive erythema and scaling conceivably could result from use on open skin lesions.

. (The following interactions are from a published review 5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Gel is not known.) I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: Drug Description of Interaction Tolbutamide; Sulfonylureas Hypoglycemia potentiated Methotrexate Decrease tubular reabsorption; clinical toxicity from methotrexate can result Oral Anticoagulants Increased bleeding II. Drugs changing salicylate levels by altering renal tubular reabsorption: Drug Description of Interaction Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism Ammonium Sulfate Increases plasma salicylate level III. Drugs with complicated interactions with salicylates: Drug Description of Interaction Heparin Salicylate decreases platelet adhesivesness and interferes with hemostasis in heparin-treated patients Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia Uricosuric Agents Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited The following alterations of laboratory tests have been reported during salicylate therapy 6 : Laboratory Tests Effect of Salicylates Thyroid Function Decreased PBI; increased T 3 uptake Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2 - 5 g qd) 5 Hydroxyindole Acetic Acid False negative with fluorometric test Acetone, Ketone Bodies False positive FeCl 3 in Gerhardt reaction; red color persists with boiling 17-OH Corticosteroids False reduced values with >4.8 g qd salicylate Vanilmandelic Acid False reduced values Uric Acid May increase or decrease depending on dose Prothrombin Decreased levels; slightly increased prothrombin time

Store at controlled room temperature 15° - 30°C (59° - 86°F). [See USP “Controlled Room Temperature”]