Tacrolimus Ointment technical specification:
| Product Name: | Retapamulin Cream 1% w/w |
| Brand Name: | Generic |
| Strength: | 0.1% w/w |
| Dosage Form: | Cream (Tube) |
| Route of Administration: | External (Topical) use |
| Packing: | 5gm,10gm, 15gm,30gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet),SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Topical antibiotic |
| Indication: | Retapamulin 1% ointment is use in adults and children older than nine months for the treatment of impetigo caused by methicillin-susceptible Staphylococcus aureus and Streptococcus pyogenes. |
| Storage: | Store below 25°C.Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Retapamulin Cream 1% w/w
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each Gram ointment contain:
Retapamulin USP ………………………….10mg
In a cream base………………………Q.S.
Methylparaben IP…………………0.18%w/w
Propylparaben IP…………………..0.02% w/w
THERAPEUTIC INDICATIONS:
Retapamulin 1% ointment is use in adults and children older than nine months for the treatment of impetigo caused by methicillin-susceptible Staphylococcus aureus and Streptococcus pyogenes.
CAUTION & SCHEDULE:
FOR EXTERNAL USE ONLY
keep the medicine out of reach of children.
Replace cap tightly after use
For dermatological use only.
Do not use in eye, mouth or lip or inside the nose
Refer enclosed prescribing information a sheet for further use
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE:
Storage: Store below 25°C. Do not freeze.