Ketoconazole Cream 2 % w/w Technical Specification:
| Product Name: | Ketoconazole Cream 2 % w/w |
| Brand Name: | Generic |
| Strength: | 2% w/w |
| Dosage Form: | Cream |
| Route of Administration: | Topical Route |
| Packing: | 15gm, 20gm, 30gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal |
| Indication: | To treat skin infections |
| Storage: | Store below 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ketoconazole Cream 2 % w/w
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Ketoconazole Cream 2 % w/w
Each Gram Contains:
Ketoconazole IP……………..…..2%w/w
Cream Base……………………….…QS
INDICATIONS:
It is used to treat skin infections such as athlete’s foot, jock itch, ringworm, and certain kinds of dandruff. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms or legs.
CAUTION & SCHEDULE:
CAUTION:
For External use only.
Avoid contact with eyes and mouth.
Keep out of reach of children.
Keep the tube tightly closed after use.
SCHEDULE:
SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store below 25°C. Do not freeze.
DOSAGE: As directed by the Physician.