Stiefel Ireland

Oilatum Junior Emollient Bath Additive

Paraffin, Light Liquid 63.4% w/w

For a full list of excipients, see section 6.1

Bath additive.

Pale yellow, odourless, oily liquid.

Oilatum Junior is indicated in the treatment of atopic eczema, contact dermatitis, senile pruritus, ichthyosis and related dry skin conditions.

Oilatum Junior should always be used with water, either added to the water or applied to wet skin.

Infant Bath

Add ½-2 capfuls to a basin of water. Apply gently over entire body with a sponge. Pat dry.

Adult or Child Bath

Add 1-3 capfuls to a 20cm (8 inch) bath of water. Soak for 10-20 minutes. Pat dry.

Skin Cleansing

Rub a small amount of oil into wet skin. Rinse and pat dry.

Oilatum Junior is most effective when it is used as a bath additive, particularly when the area of skin to be treated is extensive. In addition to its therapeutic benefits of hydration and emolliency, this method of use is particularly relevant in management of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms.

Oilatum Junior acts as a skin cleanser, and should not be used with soap.

Patients should be advised to use care to avoid slipping in the bath. It is not necessary to use soap with Oilatum Junior.

Known hypersensitivity to the ingredients.

None.

None.

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

None.

None.

Not applicable.

Light liquid paraffin exerts an emollient effect by forming an occlusive oil film in the stratum corneum. This prevents excessive evaporation of water from the skin surface, aiding hydration and lubrication.

Oilatum Junior is a topical preparation which acts at the surface of the skin. Pharmacokinetic data are not applicable to this preparation.

The active ingredient, light liquid paraffin, has been in widespread use for many years. Clinical experience has demonstrated the safety of the preparation. Pre-clinical safety data are not relevant.

Acetylated Lanolin Alcohols

Isopropyl Palmitate

Macrogol 400 Dilaurate

Macrogol ester (Polyoxyethylene 40 Sorbital Septaoleate)

Not applicable

5 years.

This medicinal product does not require any special storage conditions.

High density polyethylene bottles of 25ml, 150ml and 300ml, fitted with screw caps.

Not all pack sizes may be marketed.

No special requirements.

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel

PA 1077/125/3

Date of first authorisation: 6^th February 1998

Date of last renewal: 6^th February 2008

04/03/2011