Ciclopirox Olamine Cream Technical Specification:
| Product Name: | Ciclopirox Olamine Cream USP 0.77% w/w |
| Brand Name: | Generic |
| Strength: | 0.77% w/w |
| Dosage Form: | Cream |
| Route of Administration: | Via Oral Route |
| Packing: | 15gm, 30gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSC and CTD Dossier |
| 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 at 20-25℃ (68°F -77°F)(See USP controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Ciclopirox Olamine Cream USP 0.77% w/w
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Ciclopirox Olamine USP……….7.70mg
(In a water miscible vanishing cream base consisting of purified water USP, octyldodecanol NF, mineralcoil USP, stearyl alcohol NF, cetyl alcohol NF, cocamide DEA, polysorbate 60NF, myristylvalcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF(1%) as preservative.
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:
Keep out of reach of children.
Replace cap tightly closed after use
Reverse the cap and pierce the protective seal on tube.
Do not use if seal has been punctured or is not visible.
For dermatological use only
Not use for use in eye.
Direction of use:
Gently massage into the affected and surrounding skin area twice daily, in the morning and evening
STORAGE & DOSAGE:
Storage: Store at 20-25℃ (68°F -77°F) (See USP controlled Room Temperature).
Dosage: See insert for full prescribing information only