Clotrimazole and Beclomethasone Dipropionate Cream Technical Specification:
| Product Name: | Clotrimazole and Beclomethasone Dipropionate Cream 1%/0.05% |
| Brand Name: | Generic |
| Strength: | 1%+0.05% w/w |
| Dosage Form: | Cream |
| Route of Administration: | For topical use |
| Packing: | 45gm |
| 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 /anti-allergic |
| Indication: | Beclomethasone Dipropoanate+ Clotrimazole is used to treat fungal infections, such as ringworm of the foot (tinea pedis or athlete’s foot), ringworm of the groin (tinea cruris or jock itch), and ringworm of the body (tinea corporis). |
| Storage: | Store at 20℃ to 25℃ (68°F to 77°F), (See USP Controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Clotrimazole 1%w/w and Beclomethasone Dipropionate 0.05% Cream
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each gram contains:
10mg clotrimazole, USP and 0.64mg betamethasone dipropionate, USP (equivalent to 0.5mg betamethasone), in hydrophillic cream consisting of ceteareth-30, cetostearyl alcohol, mineral oil, phsphoric acid, propylene glycol, purified water.
THERAPEUTIC INDICATIONS:
Beclomethasone Dipropionate+ Clotrimazole is used to treat fungal infections, such as ringworm of the foot (tinea pedis or athlete’s foot), ringworm of the groin (tinea cruris or jock itch), and ringworm of the body (tinea corporis).
CAUTION:
Keep out of reach of children.
Direction for puncturing cap: Remove cap, turn cap upside down and place puncture tip into tube. Push cap until tube end is punctured. Screwed cap back on to reseal tube.
DIRECTION OF USAGE:
Apply sufficient amount of cream to the affected and surrounding skin areas twice a day.
ATTENTION PHARMACIST: Dispense with enclosed patient information leaflet.
ATTENTION PATIENT: See Patient information Leaflet before using this product.
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENT UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.
STORAGE & DOSAGE:
Storage: Store at 20℃ to 25℃ (68°F to 77°F), (See USP Controlled Room Temperature).
Dosage: Read accompanying direction carefully.