SALEX- salicylic acid cream
SALEX- salicylic acid lotion
Coria Laboratories

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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:

Chemical 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.

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.

Due to the competition of salicylate with other drugs for binding to serum albumin, the following drug interactions may occur:




Hypoglycemia potentiated.


Decreases tubular reabsorption; clinical toxicity from methotrexate can result.

Oral Anticoagulants

Increased bleeding.

Drugs changing salicylate levels by altering renal tubular reabsorption:




Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.

Acidifying Agents

Increases plasma salicylate level.

Alkalizing Agents

Decreased plasma salicylate levels.

Drugs with complicated interactions with salicylates:




Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.


Inhibits pyrazinamide-induced hyperuricemia.

Uricosuric Agents

Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited.

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



Thyroid Function

Decreased PBI; increased T3 uptake.

Urinary Sugar

False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.).

5-Hydroxyindole acetic acid

False negative with fluorometric test.

Acetone, ketone bodies

False positive FeCl3 in Gerhardt reaction; red color persists with boiling.

17-OH corticosteroids

False reduced values with >4.8g q.d. salicylate.

Vanilmandelic acid

False reduced values.

Uric acid

May increase or decrease depending on dose.


Decreased levels; slightly increased prothrombin time.

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