Ciclopirox Olamine Cream Technical Specification:
| Product Name: | Ciclopirox Olamine Cream USP 1% w/w |
| Brand Name: | Generic |
| Strength: | 1% w/w |
| Dosage Form: | Cream |
| Route of Administration: | Via Oral Route |
| Packing: | 10gm, 20gm, 30gm, 50gm, 60gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antifungal |
| Indication: | Ciclopirox Olamine cream is used to treat fungal skin infections such as athlete’s foot, jock itch, and ringworm and also pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. |
| Storage: | Store below 25℃. Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ciclopirox Olamine Cream USP 1% w/w
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Ciclopirox Olamine USP……….1.0% w/w
Benzyl alcohol IP………………….1.0%w/w
(As preservative)
Cream base………………………….q.s.
THERAPEUTIC INDICATIONS:
This cream is used to treat fungal skin infections such as athlete’s foot, jock itch, and ringworm and also pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs.
CAUTION & SCHDEDULE:
Keep out of reach of children.
Replace cap tightly closed after use
Reverse the cap and pierce the protective seal on tube.
FOR EXTERNAL USE ONLY.
SCHEDULE H DRUG: WARNINNG: Not sold by retail without prescription of the Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 25℃. Do not freeze. Protect from light.
Dosage: As directed by the Physician.