Clobetasol with Salicylic Acid

Skin conditions like psoriasis, eczema, dermatitis, and lichen planus are prevalent worldwide and significantly impact patient quality of life. In dermatology, combination therapies offer superior efficacy compared to monotherapies, especially when managing chronic inflammatory and hyperkeratotic skin disorders. One of the most effective and widely prescribed combinations in dermatological treatment is Clobetasol Propionate with Salicylic Acid.

At BluepillExpress, we offer WHO-GMP certified third-party manufacturing for Clobetasol with Salicylic Acid formulations in various dosage forms. We are an experienced pharmaceutical exporter and private-label manufacturer catering to both domestic and global clients. Our infrastructure, regulatory expertise, and flexible production capabilities make us a reliable manufacturing partner for dermatological medicines.

Product Overview

Generic Name: Clobetasol Propionate + Salicylic Acid
Therapeutic Category: Topical Corticosteroid + Keratolytic Agent
Pharmaceutical Formulations Available:

• Cream
• Ointment
• Lotion
• Scalp Application
• Gel

Common Strengths Offered:

• Clobetasol Propionate 0.05% w/w + Salicylic Acid 3% w/w
• Clobetasol Propionate 0.05% w/w + Salicylic Acid 6% w/w
  (Customized strengths available based on regulatory and client requirements)

Packaging Options:

• Lami tubes: 15 g, 20 g, 30 g, 50 g
• HDPE bottles: 50 ml, 100 ml for scalp lotions
• Cartons with multilingual labeling and leaflets
• Bulk packaging for institutional supplies

Pharmacopoeial Standards: IP / USP / BP / Client-Specific

Mechanism of Action

Clobetasol Propionate:
A superpotent topical corticosteroid that reduces inflammation, itching, and redness by inhibiting multiple inflammatory cytokines. It works through vasoconstriction, suppression of leukocyte migration, and inhibition of inflammatory mediators.

Salicylic Acid:
A keratolytic agent that softens and dissolves the stratum corneum, promoting desquamation of dead skin cells. It enhances the penetration of Clobetasol by breaking down keratin and improving drug absorption in thickened skin.

Combination Benefit:
The synergistic action of Clobetasol with Salicylic Acid offers faster and more effective relief from chronic, scaly, and inflammatory dermatoses. Salicylic acid not only reduces hyperkeratosis but also enhances corticosteroid delivery, improving clinical outcomes.

Indications

Clobetasol with Salicylic Acid combination is indicated for the treatment of:

• Chronic plaque psoriasis
• Seborrheic dermatitis
• Lichen planus
• Eczema with hyperkeratosis
• Atopic dermatitis
• Contact dermatitis (irritant or allergic)
• Scalp psoriasis and dandruff
• Hyperkeratotic skin conditions with inflammation

Dosage and Administration

Adults and Adolescents:

• Apply a thin film to the affected area once or twice daily
• Treatment duration should not exceed 2 weeks in most cases
• Scalp applications to be used as directed, preferably at night
• Avoid use on large surface areas or under occlusion unless medically advised

Pediatric Use:

• Not recommended in children under 12 unless prescribed by a healthcare professional
• Use with caution due to potential systemic absorption of corticosteroids

Precautions:

• Avoid contact with eyes, mouth, and mucous membranes
• Do not apply to broken skin or infected lesions
• Not to be used as a cosmetic skin lightening agent

Pharmacokinetics and Safety

Clobetasol Propionate:

• Minimal systemic absorption when used appropriately
• Risk of HPA axis suppression with prolonged or extensive use

Salicylic Acid:

• Systemic absorption depends on surface area, concentration, and occlusion
• Generally safe when used in prescribed concentrations and durations

Safety Profile:

• Side effects may include skin thinning, irritation, burning, dryness, or discoloration
• Rare systemic side effects in prolonged misuse
• No significant drug interactions when used topically

Benefits of Clobetasol + Salicylic Acid Combination

• Superior anti-inflammatory and keratolytic effect
• Enhanced corticosteroid penetration due to keratin breakdown
• Faster symptom relief in chronic conditions
• Reduces scale formation and itching in scalp psoriasis
• Improves patient adherence due to dual-action relief
• Effective even in thick, lichenified lesions

Why Choose BluepillExpress for Manufacturing?

1. WHO-GMP Certified Manufacturing Facilities

BluepillExpress operates internationally compliant manufacturing units equipped with:

• Dedicated topical manufacturing zones
• Automatic tube-filling, sealing, and labeling lines
• HVAC-controlled environments and microbial control zones
• Separate areas for corticosteroid formulations

2. Customizable Formulations and Packaging

We offer customized options such as:

• Alcohol-free and fragrance-free variants
• Non-greasy quick-absorption formulations
• Various tube sizes and container options
• Dermatologically tested and hypoallergenic bases
• Private label design and logo incorporation

3. Regulatory Documentation and Support

Our regulatory and QA/QC teams support:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Product Dossiers (CTD/ACTD formats)
• Clinical data (if available) and batch stability studies
• Artwork and packaging compliance with MOH standards

4. Global Export Capabilities

BluepillExpress exports Clobetasol-based combinations to:

• Africa: Nigeria, Kenya, Ethiopia, Ghana, Sudan
• Asia: Philippines, Cambodia, Vietnam, Myanmar
• Middle East: UAE, Yemen, Iraq, Jordan
• Latin America: Bolivia, Dominican Republic, Honduras
• CIS & Eastern Europe markets

We provide multilingual packaging, export-ready documentation, and end-to-end logistics coordination.

Quality Control and Assurance

We ensure rigorous testing and quality checks at every manufacturing stage:

• Raw material verification and API identification
• Assay and content uniformity for both Clobetasol and Salicylic Acid
• pH, viscosity, and rheology of creams and gels
• Microbial limit tests
• Stability testing (accelerated and real-time)
• Packaging integrity and seal verification
• Dermatological compatibility and patch testing (optional)

Every batch is released only after meeting strict internal and international quality benchmarks.

Third-Party Manufacturing Process Workflow

Step 1: Product Finalization
Finalize strength, dosage form, market requirements, and artwork details.

Step 2: Sample Development
Prototype batches and sample packaging developed and shared for approval.

Step 3: Documentation & Quotation
Regulatory documentation prepared, pricing finalized, and lead time communicated.

Step 4: Batch Production
Manufacturing initiated in WHO-GMP facilities, with in-process QC monitoring.

Step 5: Packaging & Dispatch
Finalized products packed and labeled as per client specifications. Complete documentation is provided for export or distribution.

Target Market and Clients

This product is ideally suited for:

• Dermatology brands launching prescription or OTC product lines
• Distributors and wholesalers dealing in dermatological therapies
• Government and institutional procurement for skin care programs
• Hospital chains and pharmacy networks
• Global humanitarian organizations supplying essential medicines

The demand for affordable, high-efficacy skin care products is consistently rising, especially in tropical and high-humidity regions. BluepillExpress provides the scale and consistency to support this demand globally.

Global Market Outlook

The global dermatology market is projected to reach USD 40+ billion in the next five years, with increasing demand for steroid-based combination treatments. Key drivers include:

• Rising prevalence of psoriasis and eczema
• Growing use of topical corticosteroids in OTC and Rx segments
• Increased awareness about dermatological health
• Demand for affordable, export-ready dermatological solutions

Clobetasol with Salicylic Acid continues to be a high-value product due to its effectiveness, wide therapeutic use, and favorable market acceptance.

Conclusion

The combination of Clobetasol Propionate and Salicylic Acid is a clinically effective, well-tolerated, and fast-acting treatment for a range of inflammatory and hyperkeratotic skin conditions. Its efficacy, safety, and dual-action mechanism make it a staple in dermatology practices around the world.

BluepillExpress is your trusted partner for the third-party manufacturing of this dermatological formulation, offering scalable production, quality compliance, and market-ready packaging under your brand or for institutional supply. Backed by a team of regulatory experts and WHO-GMP manufacturing capabilities, we help clients succeed in highly competitive dermatological markets.