Clobetasol Propionate + Salicylic Acid Ointment

Clobetasol + Salicylic Acid Ointment belongs to the Ointments category and is classified as a topical anti-inflammatory and keratolytic preparation. It is a Schedule H product requiring a valid medical prescription for dispensing in India.

The two-component formulation addresses multiple aspects of hyperkeratotic inflammatory skin conditions:

• Clobetasol Propionate 0.05% — a potent corticosteroid that reduces inflammation, redness, and itching
• Salicylic Acid (3% or 6.5%) — a keratolytic agent that softens and removes thickened, scaly skin layers

Saar Biotech manufactures DCGI-approved formulations of this combination ointment from our manufacturing facility in Baddi, available in 20gm and 30gm laminated tube formats.

At Saar Biotech, we manufacture Clobetasol + Salicylic Acid Ointment using a precision-controlled homogenization process that ensures every tube delivers uniform API distribution, consistent sensory performance, and stable shelf-life potency.

• Two-API Uniformity: Homogeneous dispersion of both actives is achieved through validated mixing sequence and controlled temperature homogenization.
• Viscosity Consistency: Every batch is tested for viscosity within defined specifications to ensure the ointment spreads easily and maintains correct texture.
• pH-Optimised Base: The ointment base is formulated and verified within a skin-compatible pH range to prevent irritation and maintain chemical stability.
• Tube Filling Precision: Automated laminated tube filling lines in Baddi ensure accurate fill weight per tube with minimal variation.

Clobetasol + Salicylic Acid Ointment is manufactured by Saar Biotech for the following clinically recognised indications:

• Psoriasis Vulgaris: Particularly effective for chronic, hyperkeratotic plaques
• Chronic Eczema: Steroid-responsive dermatitis with excessive scaling
• Lichen Planus: Inflammatory skin condition with hyperkeratosis
• Hyperkeratotic Dermatoses: Various skin conditions with thickened, scaly lesions
• Calluses & Corns: Thickened skin requiring keratolytic and anti-inflammatory action

How the Two Components Work Together

Clobetasol Propionate is a highly potent corticosteroid that suppresses the immune response, reduces inflammation, and alleviates symptoms such as redness, itching, and swelling by inhibiting phospholipase A2 and subsequent prostaglandin and leukotriene synthesis.

Salicylic Acid is a keratolytic agent that breaks down the intercellular cement of the stratum corneum by dissolving the desmosomal connections between corneocytes. This promotes desquamation of thickened, scaly skin and enhances penetration of the corticosteroid.

Manufacturing Integrity

• Chemical Stability: Both actives must remain chemically stable in the ointment base. Our formulation team selects appropriate excipients and preservatives that protect both actives from degradation.
• Preservation System: The ointment includes a validated preservation system that maintains microbiological integrity throughout the product’s shelf life.

Saar Biotech offers specialised Contract Manufacturing (CMO) and Third-Party Manufacturing services for Clobetasol + Salicylic Acid Ointment from our semi-solid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Dedicated semi-solid manufacturing lines with planetary mixer homogenizers and automated laminated tube filling and sealing equipment.
• Capacity: Pilot batches from 5,000 tubes to commercial runs of 1,00,000+ tubes per production cycle.
• Quality Lab: GLP-certified in-house QC with HPLC, pH metres, viscometers, and stability chambers for complete batch release testing.
• Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
• Packaging: 20gm and 30gm laminated aluminium tubes with custom mono-carton and label design.
• Regulatory: DCGI-compliant; full COA, batch records, and stability data provided.
• MOQ: 5,000–10,000 tubes per SKU per strength.

1. Sealed Tube Storage: Store below 30°C in a cool, dry location away from direct sunlight and heat sources. Do not freeze.
2. In-Use Handling: Replace the cap firmly after each use to minimise exposure to air and light.
3. Application Precautions: Apply exclusively to intact skin. Keep away from eyes, mucous membranes, and broken skin.

Every batch is released only after completing the following analytical protocol:

• HPLC Assay (Two-API): Individual assay of Clobetasol Propionate and Salicylic Acid confirming each active meets label claim per IP specifications.
• pH Testing: Verification that the ointment’s pH is within the skin-compatible specification range.
• Viscosity Testing: Measurement of ointment viscosity confirming batch-to-batch consistency.
• Microbial Limit Test (MLT): Confirms total aerobic count and absence of specified pathogens per IP limits.
• Certificate of Analysis (COA): Issued with every B2B consignment.

Common Side Effects: Burning, stinging, itching, dryness, redness, skin thinning, striae, and folliculitis.

Contraindications: Known hypersensitivity to any component. Not for use on broken skin, open wounds, or mucous membranes. Avoid contact with eyes.

Precautions: Use during pregnancy and lactation only under physician supervision. Salicylic acid may be absorbed through damaged skin; caution in renal impairment. Prolonged use of potent corticosteroids can lead to skin atrophy and striae.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Clobetasol Propionate + Salicylic Acid Ointment, please use the enquiry form below.