Hydroquinone + Tretinoin + Mometasone Furoate Cream

Hydroquinone + Tretinoin + Mometasone Furoate Cream belongs to the Creams category and is classified as a topical depigmenting and anti-inflammatory preparation. It is a Schedule H product requiring a valid medical prescription for dispensing in India.

The three-component formulation addresses multiple aspects of hyperpigmentation:

• Hydroquinone 2% — a depigmenting agent that inhibits melanin synthesis, lightening dark spots and hyperpigmented areas
• Tretinoin 0.025% — a retinoid that increases cell turnover and promotes exfoliation, renewing the skin
• Mometasone Furoate 0.1% — a corticosteroid that reduces redness, swelling, and itching

Saar Biotech manufactures DCGI-approved formulations of this combination cream from our manufacturing facility in Baddi, available in 15gm, 20gm, and 25gm 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 three active components — Hydroquinone, Tretinoin, and Mometasone Furoate — 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.

Hydroquinone + Tretinoin + Mometasone Furoate Cream is manufactured by Saar Biotech for the following clinically recognised indications:

• Melasma: Moderate to severe melasma of the face, used in conjunction with sun avoidance measures including sunscreen use

• Hyperpigmentation: Lightening of dark spots, hyperpigmentation, and uneven skin tone

• Post-Inflammatory Hyperpigmentation: Darkening of the skin following inflammation or injury

How the Three Components Work Together

Hydroquinone is a depigmenting agent that stops the synthesis of melanin by inhibiting the enzyme tyrosinase, thereby helping to lighten the skin.

Tretinoin is a retinoid that increases the cell turnover rate and helps exfoliate the skin to renew it.

Mometasone Furoate is a steroid that reduces redness, swelling, and itching.

Manufacturing Integrity

• Chemical Stability: Each active must remain chemically stable in the cream base. Tretinoin is particularly sensitive to light and oxidation, requiring careful formulation and packaging.
• Preservation System: The cream includes a validated preservative system 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.
• Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
• Packaging: 15gm, 20gm, and 25gm 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.

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 (Multi-API): Individual assay of Hydroquinone, Tretinoin, and Mometasone Furoate 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.
• Certificate of Analysis (COA): Issued with every B2B consignment.

Common Side Effects: Mild burning, stinging, redness, and dryness at the application site.

Contraindications: History of allergic reaction to hydroquinone, tretinoin, or mometasone furoate.

Precautions: Sun exposure should be strictly avoided during treatment, and sunscreen should be used regularly. Not recommended for use on children, and should be avoided during pregnancy and lactation unless specifically prescribed.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Hydroquinone + Tretinoin + Mometasone Furoate Cream, please use the enquiry form below.