FUNBACT-A Cream Ref.[115688] Active ingredients: Betamethasone Clotrimazole Neomycin

Source: Registered Drug Product Database (NG)  Revision Year: 2019  Publisher: Bliss GVS Pharma Ltd., 102, Hyde Park, Saki Vihar Road, Andheri (East), Mumbai - 400 072

4.1. Therapeutic indications

Funbact A Cream is indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected, or likely to occur.

Adults and children (aged 2 years and over): Eczema including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex and lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; insect bite reactions and anal and genital intertrigo.

4.2. Posology and method of administration

For topical administration.

Treatment should not be continued for more than 7 days without medical supervision.

Adults and children aged 2 years and over

A small quantity should be applied to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day or even less often.

When used in children, courses should be limited to 5 days, if possible.

Dosage in renal impairment

Dosage should be reduced in patients with reduced renal function.

Elderly

Funbact A cream are suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulphate may occur.

4.9. Overdose

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing's syndrome may appear and in this situation topical steroids should be discontinued gradually under medical supervision.

Also, consideration should be given to significant systemic absorption of neomycin sulphate. If this is suspected, use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store in dry place, below 30°C.

6.5. Nature and contents of container

A white soft cream in packed in printed Aluminium collapsible Tubes with rubber latex and sealed nozzle with white Piercing cap.

One filled 30 gm Aluminium Tube insert in a printed mono carton along with leaflet.

6.6. Special precautions for disposal and other handling

Do not dilute.

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