Salex

• Coria Laboratories, a division of Valeant Pharmaceuiticals North America

• Coria Laboratories, LTD

• Valeant Pharmaceuticals North America LLC

There are many brands and forms of salicylic acid available. Not all brands are listed on this leaflet.

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.

Salicylic acid topical (for the skin) is used in the treatment of acne, dandruff, seborrhea, or psoriasis, and to remove corns, calluses, and warts.

Salicylic acid topical may also be used for purposes not listed in this medication guide.

Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: hives, itching; difficult breathing, feeling light-headed; or swelling of your face, lips, tongue, or throat.

Salicylic acid topical is available in many different forms, such as liquid, gel, lotion, cream, ointment, foam, soap, shampoo, cloth pads, and skin patches. Use the medicine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. Before you start using this medicine, you may choose to apply a "test dose" to see if you have a reaction. Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day.

Do not take this medicine by mouth. It is for use only on your skin.

Gently clean and dry the affected area. When treating warts or calluses, you may gently remove any loose tissue with a soft brush, wash cloth, or nail file. Soak the skin for 5 minutes before applying the medicine.

You may need to shake the foam or lotion before use. Follow all directions on the product label.

Cut the skin patch to fit the area you are treating. Follow all directions on your medication label about how long to wear the skin patch.

Use salicylic acid topical regularly to get the most benefit. It may take up to several days before your symptoms improve.

Call your doctor if your symptoms do not improve, or if they get worse while using salicylic acid topical.

Do not use salicylic acid topical to treat any skin condition that has not been checked by your doctor.

Store at room temperature away from moisture and heat.

Keep the foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty aerosol canister.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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).

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 salicylate 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 competitive mechanisms other drugs can influence the serum levels of salicylate (See PRECAUTIONS).

For Dermatologic Use: Salex® 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: Salex® 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.

For external use only. Avoid contact with eyes and other mucous membranes.

Drug Interactions

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 Salex® is not known.

The following alterations of laboratory tests have been reported during salicylate therapy:

Pregnancy (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salex® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salex®, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salex®. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.