Clobetasol + Neomycin + Miconazole + Chlorocresol Cream

Clobetasol + Neomycin + Miconazole + Chlorocresol Cream belongs to the Creams category and is classified as a topical anti-inflammatory, antifungal, antibacterial, and antiseptic preparation. It is a Schedule H product requiring a valid medical prescription for dispensing in India.

The four-component formulation addresses multiple aspects of mixed skin infections:

• Clobetasol Propionate 0.05% — a potent corticosteroid that reduces inflammation, redness, and itching
• Neomycin Sulphate 0.5% — an aminoglycoside antibiotic effective against a variety of bacteria
• Miconazole Nitrate 2% — an azole antifungal that inhibits ergosterol synthesis
• Chlorocresol 0.1% — an antimicrobial preservative with bactericidal and fungicidal properties

Saar Biotech manufactures DCGI-approved formulations of this combination cream from our manufacturing facility in Baddi, available in 15gm, 20gm, and 30gm laminated tube formats.

At Saar Biotech, we manufacture this combination cream using a precision-controlled homogenization process that ensures every tube delivers uniform API distribution, consistent sensory performance, and stable shelf-life potency.

• Multi-API Uniformity: Homogeneous dispersion of four active components — Clobetasol, Neomycin, Miconazole, and Chlorocresol — is achieved through a validated mixing sequence and controlled temperature homogenization.

• Viscosity Consistency: Every batch is tested for viscosity within a defined specification range to ensure the cream spreads easily on application and maintains the correct texture through its 24-month shelf life.

• pH-Optimised Base: The cream base is formulated and verified within a skin-compatible pH range to prevent cutaneous irritation and maintain the chemical stability of all actives.

• Tube Filling Precision: Automated laminated tube filling lines in Baddi ensure accurate fill weight per tube with minimal variation.

Clobetasol + Neomycin + Miconazole + Chlorocresol Cream is manufactured by Saar Biotech for the following clinically recognised indications:

• Mixed Skin Infections: Infections where inflammation, fungal infections, bacterial infections, and the need for antiseptic protection coexist

• Inflammatory Skin Conditions with Secondary Infection: Conditions where primary skin inflammation has been complicated by secondary bacterial or fungal infection

• Dermatophyte Infections: Fungal skin infections that have become secondarily infected with bacteria

• Eczematous Dermatitis with Infection: Eczematous conditions complicated by bacterial or fungal superinfection

How the Four Components Work Together

Clobetasol Propionate is a potent corticosteroid that suppresses the immune response, reduces inflammation, and alleviates symptoms such as redness, itching, and swelling.

Neomycin Sulphate is an antibiotic that interferes with bacterial protein synthesis. It is effective against a variety of bacteria and helps prevent or treat bacterial infections.

Miconazole Nitrate is an antifungal medication that works by inhibiting the synthesis of ergosterol, a component of the fungal cell membrane. This disruption weakens the cell membrane, leading to the death of the fungus.

Chlorocresol is an antimicrobial agent with bactericidal and fungicidal properties. It works by disrupting the cell membrane of microorganisms, leading to their destruction.

Manufacturing Integrity

• Chemical Stability: Each active must remain chemically stable in the cream base. Our formulation team selects preservatives and pH buffers that protect all actives from degradation.

• Preservation System: The cream includes a validated preservative system (Chlorocresol) that maintains microbiological integrity throughout the product’s shelf life.

Saar Biotech offers specialised Contract Manufacturing (CMO) and Third-Party Manufacturing services for this combination cream 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: 15gm, 20gm, and 30gm laminated aluminium tubes with custom mono-carton, flap carton, and label design.
• Regulatory: DCGI-compliant; full COA, batch records, and stability data provided. Brand name search and approval support available.
• MOQ: 5,000–10,000 tubes per SKU, with flexibility for new entrants.

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 of the product 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 (Multi-API): Individual assay of Clobetasol Propionate, Neomycin Sulphate, and Miconazole Nitrate confirming each active meets label claim per IP specifications.
• pH Testing: Verification that the cream’s pH is within the skin-compatible specification range.
• Viscosity Testing: Measurement of cream 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: Itching, irritation, dry skin, thinning of skin, burning sensation, redness at the site of application.

Contraindications: Patients with a history of hypersensitivity or allergic reactions to any of the components.

Precautions: Avoid contact with eyes, nose, mouth, broken skin, or open wounds. Pregnant or breastfeeding individuals should consult their healthcare provider before using this formulation. Prolonged use of corticosteroids like Clobetasol can lead to skin atrophy, striae, and other skin changes.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Clobetasol + Neomycin + Miconazole + Chlorocresol Cream, please use the enquiry form below.