DailyMed Label: Salicylic Acid 6 percent

DailyMed Label: SALICYLIC ACID

2024

DailyMed Prescription

SALICYLIC ACID

SALICYLIC ACID

Acella Pharmaceuticals, LLC

NDC: 42192-130

NDC: 42192-130

NDC: 42192-130

Salicylic Acid 6% Foam is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. Each gram of Salicylic Acid 6% Foam contains salicylic acid 6% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, methylcellulose, methylparaben, phenoxyethanol, polyoxyl 40 stearate, polysorbate 20, polysorbate 80, povidone, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearic acid and trolamine and in propellants butane and propane.

For Dermatologic Use: Salicylic Acid 6% Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris and psoriasis. For Podiatric Use: Salicylic Acid 6% Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.

Unless otherwise directed by a prescribing physician, Salicylic Acid 6% Foam should be applied to the affected area twice a day. Salicylic Acid 6% Foam should be rubbed into the skin until it is completely absorbed. Salicylic Acid 6% Foam should be shaken vigorously before each application and inverted to administer.

DOSAGE - See WARNINGS

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

Salicylic Acid 6% Foam should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. Salicylic Acid 6% Foam should not be used on any skin area where inflammation or exudation is present as increased absorption may occur. If redness or irritation occurs, discontinue use and consult with prescribing physician.

Transient stinging, burning, itching or irritation is possible. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician.

(The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Foam 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 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 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

Salicylic Acid 6% Foam is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the NDC Number 42192-112-70 and a 200 gram or 7.1 ounce aerolized canister bearing the NDC Number 42192-130-02 .

Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis. The mechanism of action has been attributed to dissolution of intercellular cement substance. In a study of the percutaneous absorption of salicylic acid from Salicylic Acid 6% Foam in four patients with extensive active psoriasis, Taylor and Halprin showed that peak serum 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/100mL). Peak serum levels occurred within 5 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 ). The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%). The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs. By similar competetive mechanisms other drugs can influence the serum levels of salicylate. (See PRECAUTIONS ).

NDC 42192-130-02 SALICYLIC ACID 6% FOAM Hydrating Topical Foam Rx Only Net Wt. 7.1 oz. (200 g) Acella Pharmaceuticals LLC container-200 g