FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

Salex® Cream contains 6% salicylic acid USP incorporated into a patented Multivesicular Emulsion (MVE®) vehicle consisting of ammonium lactate, behentrimonium methosulfate, cetearyl alcohol, cetyl alcohol, dimethicone 360, disodium EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water and trolamine.

Salex Lotion contains 6% w/w salicylic acid USP incorporated into a patented Multivesicular Emulsion (MVE) vehicle consisting of ammonium lactate, behentrimonium methosulfate, cetearyl alcohol, cetyl alcohol, dimethicone 360, disodium EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, propylparaben, purified water and trolamine.

Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure:

This MVE formulation has been shown to provide gradual and prolonged release of the active ingredient into the skin.1

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 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 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.

Salex should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex should not be used in children under 2 years of age.

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. 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, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salex should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate-containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

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

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

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

(See WARNINGS.)

The preferable method of use is to apply Salex thoroughly to the affected area and to cover the treated area at night after washing and before retiring. Preferably, the skin should be hydrated for at least 5 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 Salex 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. (See WARNINGS.) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salex will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

Salex® Cream is available in a 454 g (16 oz.) jar - NDC 13548-010-16

Salex® Lotion is available in a 8 fl. oz. (237 mL) bottle - NDC 13548-011-08

1 Data on file.

Manufactured for:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By:

Denison Pharmaceuticals, LLC

Lincoln, RI 02865 USA

U.S. Patent Number: 6,709,663

REORDER NO.

Salex® Cream: 13548-010-18

Salex® Lotion: 13548-011-10

Salex is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

MVE is a registered trademark of DFB Technology, Ltd. used under license.

© 2019 Valeant Pharmaceuticals North America LLC

Rev. 01/2019

9497702

70014101

NDC 13548-010-18

Rx only

Salex®

(6% Salicylic Acid)

Cream

For Topical Use Only

•

1 jar of Salex® Cream

– Net Wt. 454 g (16 oz.)

Bonus: 1 bottle of PURPOSE® Gentle Cleansing Wash

- 12 fl. oz. (355 mL)

VALEANT

NDC 13548-011-10

Rx only

Salex®

(6% w/w Salicylic Acid)

Lotion

For Topical Use Only

Not for Ophthalmic,

Oral or Intravaginal Use

•

1 bottle of Salex® Lotion

- 8 fl. oz. (237 mL)

Bonus: 1 bottle of PURPOSE® Gentle Cleansing Wash

- 12 fl. oz. (355 mL)

VALEANT