Aliclen Shampoo

Generic name:salicylic acid
Dosage form: shampoo
Drug classes:Topical acne agents, Topical keratolytics

Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION
Aliclen Shampoo contains 6% w/w salicylic acid USP in a vehicle consisting of purified water USP, acrylates copolymer, edetate disodium USP, lauramide DEA, sodium chloride USP, triethanolamine lauryl sulfate, trolamine, fragrance.

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

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 glucu