WHO-GMP Certified Commercial Pack · Product Code: AKP-067
Neomycin Sulphate 0.5%, Beclomethasone Dipropionate 0.025%, Clotrimazole 1.0% & Lignocaine HCl 2.0% Ear Drops
Formulation Overview: Comprehensive four-in-one antibacterial, antifungal, anti-inflammatory corticosteroid, and local anaesthetic ear drop targeting mixed otomycosis and painful swimmer's ear. Formulated with Neomycin Sulphate 0.5% + Beclomethasone Dipropionate 0.025% + Clotrimazole 1.0% + Lignocaine HCl 2.0% (0.5% + 0.025% + 1.0% + 2.0% w/v) in Sterile Multi-Action Ear Drops dosage form under Ophthalmic & Otic Care, manufactured to IP / BP / USP Compendial standards and supplied in 5 ml / 10 ml Dropper Bottle with Individual Carton 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-067 |
|---|---|
| Therapeutic Sector | Ophthalmic & Otic Care |
| Dosage Form | Sterile Multi-Action Ear Drops |
| Active Ingredient | Neomycin Sulphate 0.5% + Beclomethasone Dipropionate 0.025% + Clotrimazole 1.0% + Lignocaine HCl 2.0% |
| Strength / Purity | 0.5% + 0.025% + 1.0% + 2.0% w/v |
| Clinical Indication | Mixed bacterial and fungal otitis externa (otomycosis), ear canal pruritus, edema, and otalgia |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 5 ml / 10 ml Dropper Bottle with Individual Carton |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light; external ear canal use only |
| 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 |