Stiefel Ireland

Oilatum Junior Flare-Up Bath Additive

For a full list of excipients see section 6.1.

Bath additive

Clear pale yellow oily solution

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

Oilatum Junior Flare-Up should always be diluted with water. It is an effective cleanser and should not be used with soap

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

Infants: 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.

The preparation should not be applied directly to the skin.

None known.

There are no restrictions on the use of Oilatum Junior Flare-Up in pregnancy and lactation.

None.

Hypersensitivity reactions, and contact dermatitis with triclosan, have been reported on occasions.

Accidental ingestion: Oilatum Junior Flare-Up is intended for topical use only. Ingestion may cause gastro-intestinal irritation with vomiting and diarrhoea. Vomitting 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 fluorescin stain. If there is persistent irritation or any uptake of fluorescin, the patient should be referred for ophthalmic 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 pamitate

Oleyl alcohol

Macrogol lauryl ether

Not applicable.

3 years

No special precautions for storage.

White HDPE bottle containing 150 ml or 300 ml, fitted with a screw cap.

No special requirements.

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel

PA 1077/126/001

Date of first authorisation: 25^th May 1989.

Date of last renewal: 19 March 2009.

3^rd December 2010