Salex Shampoo: Package Insert / Prescribing Info

Salex Shampoo Description

Salex ® Shampoo contains 6% w/w salicylic acid USP in a vehicle consisting of purified water, acrylates copolymer, sodium laureth sulfate, trolamine, quaternium 26 and propylene glycol, cocamidopropyl betaine, behentrimonium methosulfate and cetearyl alcohol, propylparaben, methylparaben, glycerin, disodium EDTA and chamomile tea fragrance.

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

Salex Shampoo - Clinical Pharmacology

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)

Indications and Usage for Salex Shampoo

For Dermatologic Use: Salex ® Shampoo 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 ® Shampoo 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.

Contraindications

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

Warnings

Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more 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.

Precautions

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

Adverse Reactions/Side Effects

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

Overdosage

See Warnings.

Salex Shampoo Dosage and Administration

Wet hair and apply Salex ® Shampoo to the scalp. Work into a lather then rinse. Repeat the treatment as needed until the condition clears. Once clearing is apparent, the occasional use of Salex ® Shampoo will usually maintain the remission.

How is Salex Shampoo supplied

Salex ® Shampoo is available in 6 fl. oz. (177 mL) bottle (NDC 0295-1042-23).

Distributed by:

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

REORDER NO.

Salex ® Shampoo: 0295-1042-23

Salex is a trademark of Valeant Pharmaceuticals

International, Inc. or its affiliates.

© Valeant Pharmaceuticals North America LLC

9492700

PRINCIPAL DISPLAY PANEL - 454 g Carton

NDC 0295-1042-23

Rx only

Salex®

(6% w/w Salicylic Acid)

Shampoo

6 fl. oz.

(177mL)