Reckitt Benckiser Ireland Limited

E45 Cream

White Soft Paraffin 14.5% w/w

Light Liquid Paraffin 12.6% w/w

Anhydrous Lanolin 1.0% w/w

Also contains:

For a full list of excipients, see section 6.1.

Cream.

Smooth white or practically white cream with not more than a slight odour.

For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, dermatitis, sunburn, the dry stage of eczema and for use as emollient adjunctive therapy in the treatment of dry cases of psoriasis.

For topical application.

Adults, Children and Elderly - Apply to the affected part two or three times daily.

Hypersensitivity to any of the ingredients.

The labelling states:

For external use only.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach and sight of children.

May cause allergic reactions (possibly delayed), such as local skin reactions.

No clinically significant interactions known.

No clinically significant interactions known.

No adverse effects known.

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.

Not applicable.

There are no preclinical safety data of relevance to the consumer.

Glyceryl monostearate,

cetyl alcohol,

sodium cetostearyl sulphate,

carbomer,

methyl hydroxybenzoate (E218),

propyl hydroxybenzoate (E216),

sodium hydroxide,

citric acid monohydrate,

purified water.

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.

2 years-Polyethylene tubes

3 years-Aluminium tubes, polypropylene tubs/pots

Do not store above 25ºC.

A polyethylene tube with membrane seal and plastic screw cap.

Pack sizes 15 or 50g.

A polypropylene securipot with a white polythene pilfer-proof screw cap.

Pack sizes: 125g, 350g and 500g.

A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or a polypropylene dispenser having a polythene covered follower plate.

Pack sizes: 500 or 900g.

A pump pack, made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g.

Not all pack sizes are necessarily marketed.

No special requirements.

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24.

PA 979/43/1

6^th June 1984/6^th June 2004

February 2011