Xylometazoline 0.05% Pediatric Nasal Spray

Xylometazoline 0.05% Nasal Spray belongs to the Nasal Sprays category and is classified as a topical nasal decongestant. It is a Schedule H product requiring a valid medical prescription for dispensing in India.

Key clinical characteristics:

• Indication: Temporary relief of nasal congestion in children aged 2 to 12 years
• Mechanism: Vasoconstriction of nasal blood vessels
• Onset: Fast-acting decongestion
• Duration: Up to 10 hours per dose
• Maximum Use: 3 days to avoid rebound congestion

Saar Biotech manufactures DCGI-approved formulations of Xylometazoline 0.05% Nasal Spray from our manufacturing facility in Baddi, available in 10ml and 15ml metered-dose pump spray bottles.

At Saar Biotech, we manufacture pediatric nasal sprays using sterile filling techniques and precision metered-dose pumps to ensure consistent, reliable delivery.

• Sterile Manufacturing: Nasal products must be free of pathogenic microbes. Our facility utilizes sterile compounding vessels and ISO Class 7 cleanrooms.

• Precision Actuator Technology: We source and utilize premium metered-dose actuators that deliver a precisely calibrated spray, ensuring uniform droplet size for optimal mucosal coverage.

• pH-Buffered Formulation: The solution is maintained in a physiologically compatible pH range to prevent mucosal irritation.

• Moisturising Formulation: Contains ingredients that help prevent the nasal mucosa from drying out.

Xylometazoline 0.05% Nasal Spray is manufactured by Saar Biotech for the following clinically recognised indications:

• Nasal Congestion: Temporary relief from stuffy noses caused by common cold, flu, and allergic conditions

• Allergic Rhinitis: Relief from congestion and symptoms associated with hay fever and other allergies

• Sinusitis: Helps open up blocked nasal airways for easier breathing

How Xylometazoline Works

Xylometazoline is a topical decongestant that acts locally on the nasal mucosa. It works by narrowing the blood vessels (vasoconstriction) in the nasal passages, providing temporary relief from nasal congestion and blockage. This helps the child to breathe more easily.

Manufacturing Integrity

• Sterility Assurance: The product is manufactured using sterile compounding and filling techniques to ensure absolute purity.
• Dose Uniformity: Metered-dose pumps are calibrated to deliver consistent spray volume with each actuation.
• Preservative System: A validated preservative system maintains product sterility throughout the shelf life.

Saar Biotech offers specialised Contract Manufacturing (CMO) and Third-Party Manufacturing services for Xylometazoline 0.05% Nasal Spray from our sterile manufacturing facility in Baddi, Himachal Pradesh.

• Facility: ISO Class 7 cleanrooms dedicated to sterile liquid processing, featuring automated bottle filling and actuator-crimping lines.
• Capacity: Scalable from 5,000 units to commercial runs of 1,00,000+ units.
• Quality Lab: GLP-certified in-house QC with HPLC, pH metres, and microbial testing capability.
• Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
• Packaging: 10ml and 15ml metered-dose pump spray bottles with custom mono-carton and label design.
• Regulatory: DCGI-compliant; full COA, batch records, and stability data provided.
• MOQ: 5,000–10,000 units per SKU.

1. Sealed Product Storage: Store below 30°C in a dry location, away from direct sunlight. Do not freeze.
2. In-Use Period: Once opened, the product should be used within the labelled period.
3. Hygiene: The spray nozzle should be wiped clean after each use and the protective cap replaced.
4. Administration Posture: Children should keep their head upright and sniff gently while depressing the pump.

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

• HPLC Assay: Confirmation of Xylometazoline 0.05% label claim accuracy.
• pH Testing: Verification that the solution is within the physiological buffer range.
• Spray Pattern & Dose Uniformity: Testing to ensure consistent delivery per actuation.
• Microbial Limit Test (MLT): Confirms the absence of specified pathogens.
• Certificate of Analysis (COA): Issued with every B2B consignment.

Common Side Effects: Nasal dryness, headache, diarrhoea, mild irritation at the application site.

Contraindications: Narrow-angle glaucoma, atrophic rhinitis, liver/kidney disease. Not recommended for infants below one year of age.

Precautions: Use should be limited to 3 days to avoid rebound congestion. For nasal application only; avoid contact with eyes.

For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Xylometazoline 0.05% Pediatric Nasal Spray, please use the enquiry form below.