WHO-GMP Certified Commercial Pack · Product Code: AKP-076
Xylometazoline Hydrochloride 0.05% w/v Nasal Spray
Formulation Overview: Paediatric-strength alpha-adrenergic topical vasoconstrictor nasal solution relieving blocked pediatric nasal airways within 5 minutes for up to 10 hours. Formulated with Xylometazoline Hydrochloride IP 0.05% w/v (0.05% w/v) in Paediatric Decongestant Nasal Spray dosage form under Respiratory & Allergy, manufactured to IP / BP / USP Compendial standards and supplied in 10 ml Metered / Squeeze Nasal Spray Bottle with Dust Cap with complete eCTD/ACTD regulatory dossiers, Zone IVb stability, and batch CoA for African NRAs (NAFDAC, PPB, SAHPRA, TMDA, FDA Ghana) and global tenders.
| Item Code (SKU) | AKP-076 |
|---|---|
| Therapeutic Sector | Respiratory & Allergy |
| Dosage Form | Paediatric Decongestant Nasal Spray |
| Active Ingredient | Xylometazoline Hydrochloride IP 0.05% w/v |
| Strength / Purity | 0.05% w/v |
| Clinical Indication | Paediatric nasal congestion due to common cold, sinusitis, and allergic rhinitis (children 2–12 years) |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 ml Metered / Squeeze Nasal Spray Bottle with Dust Cap |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light; limit continuous use to 5–7 days |
| Minimum Order Quantity | 1000 Packs |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial Export Ready |