Tacrolimus Ointment technical specification:
| Product Name: | Tacrolimus Ointment 0.03% w/w |
| Brand Name: | Generic |
| Strength: | 0.1% w/w, 0.03% w/w |
| Dosage Form: | Ointment(Tube) |
| Route of Administration: | External (Topical) use |
| Packing: | 5gm,10gm,20gm,30gm,40gm,100gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Treat eczema (atopic dermatitis) |
| Indication: | Tacrolimus is a prescription non-steroid medication used short-term on the skin to treat moderate to severe atopic dermatitis in patients who have received other medicines that have not worked well. |
| Storage: | Store at a temperature not exceeding 25°C.Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tacrolimus Ointment 0.03% w/w
Tacrolimus Ointment 0.1% w/w
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Each Gram ointment contain:
Tacrolimus IP …………….0.03%w/w
In a cream base………. Q.S.
THERAPEUTIC INDICATIONS:
Tacrolimus is a prescription non-steroid medication used short-term on the skin to treat eczema (atopic dermatitis). It’s for both adults and children 2 years of age and older who don’t have a weakened immune system.
CAUTION & SCHEDULE:
FOR EXTERNAL USE ONLY
keep the medicine out of reach of children.
Replace cap tightly after use
Refer enclosed prescribing information a sheet for further use
Avoid contact with eye.
Do not touch the tip.
Do not use any outside article to puncture the diagram.
If irritation persists or increases, discontinue the use and consult Physician.
SCHEDULE: SCHEDULE H PRESCRIPTION: WARNING: To be sold by retail on the prescription of a Dermatologist only.
STORAGE:
Storage: Store at a temperature not exceeding 25°C.Do not freeze.