ACTION AND MECHANISM Keratolytic, antiseptic and antipruritic effective for the symptomatic relief of desquamative, psoriasiform conditions and seborrheic dermatitis of the scalp. CONTRAINDICATIONS - Hypersensitivity to any of the components of the formulation. PHARMACOKINETICS Topical dermal route: Studies have shown that cutaneous absorption of coal tar and salicylic acid occurs after topical administration; however, the amounts absorbed and present in plasma were always very low. Plasma concentrations after topical administration of 10 to 20 g of a 6% salicylic acid gel, under occlusion for 10 hours, were very low (less than or equal to 5 mg/100 ml) and well below toxic levels (40 mg/100 ml). The patterns of metabolism, protein binding, and excretion after topical administration of salicylic acid are identical to those after systemic administration. Given that in clinical practice the amount administered is approximately 15 ml per application and that ionil shampoo contains 2% salicylic acid and 4.25% coal tar, the amount per application of each active ingredient cannot be greater than 0.3 g and 0.6375 g, respectively, that is, for an average weight of 70 kg, it could not be greater than 0.0042 g/kg and 0.091 g/kg of salicylic acid and coal tar, respectively. INDICATIONS - Symptomatic relief of scaly scalp disorders such as [SEBORRHEIC DERMATITIS], [PSORIASIS], [DANDRUFF] and [PRURITUS]. INTERACTIONS The simultaneous use of coal tar with photosensitizing medications may produce additive photosensitizing effects. The simultaneous use of coal tar with systemic or topical methoxsalen or trioxsalen is not recommended. CHILDREN In children, there may be a greater risk of secondary toxicity due to greater absorption of salicylic acid through the skin and the greater body surface area/treated surface area ratio, so caution should be exercised when using it in children. GUIDELINES FOR PROPER ADMINISTRATION Apply the shampoo to wet hair. Gently massage and rinse. Repeat, leaving the product on for a few minutes before rinsing. Rinse thoroughly. POSOLOGY - Topical: 1 or 2 times per week, for 2 to 4 weeks or as frequently as required for the treatment of the hair disorder. PRECAUTIONS - Avoid contact with eyes and mucous membranes. If the product accidentally comes into contact with the eyes, rinse with clean, lukewarm water. - In case of acute inflammation, open wounds, and skin infection, the benefit/risk ratio should be assessed. ADVERSE REACTIONS Occasionally: erythema, dryness, contact dermatitis, folliculitis, skin irritation, acneiform rash, burning or stinging sensation and rarely photosensitivity of the skin. COMPOSITION Coal pitch: 42.5 milligrams SALICYLIC ACID: 20 MILLIGRAMS