This ointment is indicated for the relief of inflammatory symptoms associated with hyperkeratotic and dry corticosteroid-responsive dermatoses such as psoriasis, chronic atopic dermatitis, neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, hand eczema, and eczematous dermatitis), seborrheic dermatitis of the scalp, ichthyosis vulgaris, and other ichthyotic conditions.

Clobetasol Propionate is a high-potency corticosteroid. It reduces inflammation by stabilizing lysosomal membranes of leukocytes, preventing the release of destructive enzymes, inhibiting macrophage accumulation in inflamed tissues, reducing adhesion of leukocytes to capillary endothelium, decreasing capillary permeability and edema formation, lowering complement activity, and suppressing histamine action. It also reduces fibroblast proliferation, collagen formation, and scar tissue development.

Salicylic acid acts as a potent keratolytic agent with mild antiseptic properties when applied topically. It increases hydration within the skin, leading to softening and shedding of the outer keratin layer. At higher concentrations, it may have a caustic effect. It also exhibits mild antifungal and antibacterial activity.

Adult: Apply a thin layer of this ointment to the affected skin areas twice daily and rub in gently & completely. For some patients, adequate maintenance therapy may be achieved with less frequent application. As with other higher active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. It should not be used with occlusive dressing. Treatment beyond 2 consecutive weeks is not exceeding 50 gm/week because of the potential for the drug to suppress the hypothalamic pituitary adrenal axis.

Children: Use in pediatric patients under 12 years of age is not recommended.

No interactions have been reported with Clobetasol Propionate ointment or cream. Salicylic Acid also has no known significant interactions when used as directed. However, topical salicylic acid may increase the absorption of other topical medications. Therefore, concurrent use of salicylic acid with other topical products on the same area of skin should be avoided.

Clobetasol Propionate is contraindicated in patients with known hypersensitivity to it. This preparation should not be used for untreated primary bacterial or fungal skin infections, primary viral infections (such as herpes simplex, vaccinia, varicella), or tuberculous skin conditions. It is also contraindicated in children under one year of age, including those with dermatitis or diaper rash. Salicylic Acid is contraindicated in individuals with hypersensitivity to salicylates or any other ingredient of the formulation.

Similar to other topical corticosteroids, prolonged use of large quantities of Clobetasol Propionate or application over wide areas may lead to sufficient systemic absorption, resulting in signs of hypercortisolism. This risk is higher in infants and children, especially when occlusive dressings are applied. Prolonged treatment may also cause local skin atrophy. In rare cases, the use or withdrawal of corticosteroids in psoriasis may trigger pustular psoriasis. Clobetasol Propionate is generally well tolerated; however, if hypersensitivity reactions occur, treatment should be discontinued immediately. Salicylic Acid may cause irritation, dryness, and sensitivity reactions.

Topical corticosteroids have shown adverse effects on fetal development in animal studies, though relevance to humans is unclear. Clobetasol Propionate should be used during pregnancy and lactation only if the expected benefit outweighs the potential risk. It should not be used extensively, in large amounts, or for prolonged periods during pregnancy. Although no specific contraindications exist for salicylic acid use during pregnancy and breastfeeding, its safety has not been fully established; therefore, it should be used with caution.

Clobetasol Propionate should be used cautiously on areas near the eyes. Prolonged use over large areas may lead to systemic absorption and adrenal suppression, especially in children who are more susceptible due to a higher surface area-to-body weight ratio. Topical corticosteroids require careful use in psoriasis due to risks such as relapse, tolerance, generalized pustular psoriasis, and systemic toxicity from impaired skin barrier function. If inflammatory lesions become infected, appropriate antimicrobial therapy should be initiated. If infection spreads, topical corticosteroid therapy should be discontinued and systemic antimicrobial treatment started. Occlusive dressings can increase the risk of bacterial infection; therefore, the skin should be cleaned before applying a new dressing. Avoid application on broken or inflamed skin. Salicylate toxicity may occur if applied over large areas or in neonates.

Acute overdose is unlikely. However, chronic overuse may lead to hypercortisolism, requiring gradual withdrawal of the topical steroid under medical supervision due to the risk of adrenal suppression. Systemic salicylate toxicity symptoms such as tinnitus, dizziness, and deafness have been reported with excessive or prolonged use over large areas. Salicylism is unlikely when used as directed. Toxicity is usually associated with plasma salicylate levels above 350 mg/L, with severe toxicity above 700 mg/L. Single doses below 100 mg/kg are unlikely to cause serious toxicity.

Clobetasol / Clobetasone & Combined Preparations

Store in a cool and dry place, protected from light.