Stiefel Ireland

Oilatum Plus Bath Additive.

Light liquid paraffin 52.5% w/w

Benzalkonium chloride 6.0% w/w

Triclosan 2.0% w/w

For a full list of excipients, see section 6.1

Bath additive

A clear, pale yellow oily solution.

For the treatment of infected eczemas and eczemas at risk from infection.

Oilatum Plus should always be diluted with water. It is an effective cleanser and should not be used with soap.

Bath: In an eight inch bath add 2 capfuls, in a four inch bath add 1 capful.

Infant bath: Add 1 ml (just sufficient to cover the bottom of the cap) and mix well with water.

Soak for 15 minutes, gently pat the skin dry with a clean towel. Use once daily.

Patients with known hypersensitivity to any of the ingredients should not use the product.

Not recommended for babies younger than 6 months.

Avoid contact of the undiluted product with the eyes.

Take care to avoid slipping in the bath.

None known.

There are no restrictions on the use of Oilatum Plus in pregnancy and lactation.

None.

None known.

Accidental ingestion: Oilatum Plus is intended for topical use only. Ingestion may cause gastro-intestinal irritation with vomiting and diarrhoea. Vomiting may result in foam aspiration. In the case of accidental ingestion, give 1 to 2 glasses of milk or water. If a large quantity of the product is ingested, the patient should be observed in hospital and the use of activated charcoal may be considered.

If the undiluted product comes into contact with the eye, reddening and watering may occur. Eye irrigation should be performed for 15 minutes and the eye examined under fluorescein stain. If there is persistent irritation or any uptake of fluorescein, the patient should be referred for ophthalmological opinion.

Benzalkonium chloride and triclosan are anti-bacterial agents with proven efficacy against Staphylococcus aureus, the principal causative organism in infected eczemas.

Light liquid paraffin is an emollient widely used in the treatment of eczema.

Not applicable.

Not applicable.

Acetylated wool alcohols

Isopropyl palmitate

Oleyl alcohol

Macrogol lauryl ether

Not applicable.

3 years

This medicinal product does not require any special storage conditions.

PVC or HDPE bottle containing 150ml, 250ml, 500ml or 1 litre fitted with a urea screw cap.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel

PA 1077/126/002

Date of first authorisation: 25 May 1989

Date of last renewal: 25 May 2009

3^rd December 2010