Terbinafine Cream IP Technical Specification:
| Product Name: | Terbinafine Cream IP |
| Brand Name: | Generic |
| Strength: | 1% w/w |
| Dosage Form: | Cream |
| Route of Administration: | Topical Route |
| Packing: | 10gm, 15gm, 20gm, 30gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal |
| Indication: | To treat Fungal infections |
| Storage: | Store below 30°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Terbinafine Cream IP
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Terbinafine Cream IP
Each Gram Contains:
Terbinafine Hydrochloride IP….1 %w/w
Bnezyl Alcohol IP…………….….1%w/w
Cream Base………………………..…QS
INDICATIONS:
It is used to treat fungus infections of the scalp, body, groin (jock itch), feet (athlete’s foot), fingernails and toenails.
CAUTION & SCHEDULE:
CAUTION:
For External use only.
Avoid contact with eyes and mouth.
Keep out of reach of children.
Pierce the seal of the tube with the spike provided in the cap. Replace cap tightly 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 30°C. Do not freeze.
DOSAGE: As directed by the Physician.