Itraconazole Cream Technical Specification:
| Product Name: | Itraconazole Cream 1% w/w |
| Brand Name: | Generic |
| Strength: | 1% w/w |
| Dosage Form: | Cream |
| Route of Administration: | External application |
| Packing: | 20gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristic) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal |
| Indication: | Itraconazole cream is used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi. |
| Storage: | Store at dry place, temperature not exceed than 25℃, protected from heat and light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Itraconazole 1% w/w Cream
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Itraconazole IP……………1%w/w
Preservative:
Methyl paraben IP……….0.1%w/w
Propyl paraben IP…………0.05%w/w
Gel base…………………………q.s.
THERAPEUTIC INDICATIONS:
Itraconazole cream is used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.
CAUTION:
Keep out of reach of children.
Replace Cap tightly after use.
DIRECTION OF USE:
Apply 3-4 times daily over affected area as directed by Physician.
SCHEDULE:H DRUG:WARNING: Not sold by retail without prescription of the Registered Medical Practitioner Only.
STORAGE & DOSAGE:
Storage: Store at dry place, temperature not exceed than 25℃, protected from heat and light.
Dosage: As directed by Physician.