Dermal Laboratories Limited

EMULSIDERM™ EMOLLIENT BATH ADDITIVE/CUTANEOUS EMULSION

Liquid Paraffin 25.0% w/w; Isopropyl Myristate 25.0% w/w; Benzalkonium Chloride 0.5% w/w.

Bath additive or cutaneous emulsion.

Pale blue-green oil-in-water emulsion.

As an adjunct in the management of dry skin, by rehydration with antisepsis. Emulsiderm Emollient contains benzalkonium chloride. Benzalkonium chloride may be useful in preventing Staphylococcus aureus, a pathogen which often complicates atopic eczema and associated pruritis. Emulsiderm is specially formulated in a unique emulsion system optimised for convenient application to the skin, either via the patient's bath water or directly.

For adults, children and the elderly:

For use in the bath Add 7 - 30 ml Emulsiderm to a bath of warm water (more or less according to the size of the bath and individual patient requirements).

Soak for 5 - 10 minutes. Pat dry.

For application to the skin Rub a small amount of undiluted emollient into the dry areas of skin until absorbed.

Sensitivity to any of the ingredients.

Keep away from the eyes. For external use only. Keep out of the reach and sight of children. Take care to avoid slipping in the bath.

None known.

No known side effects.

None known.

Although the emollient has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment.

These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic/hypersensitive in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.

Not applicable.

For dry skin conditions it is important to add an emollient to the bath water. Emulsiderm contains 50% of oils emulsified in water as well as the well-known antiseptic, benzalkonium chloride, which assists in overcoming secondary infection.

Emulsiderm contains 0.5% of the quaternary ammonium antiseptic, benzalkonium chloride. The large positively charged cation is readily adsorbed from the formulation onto negatively charged bacterial cell surfaces, thereby conferring substantial antimicrobial activity. Even at extended dilution in vitro, it is particularly effective against Staphylococcus aureus, a bacterium which is known to colonise the skin in large numbers in patients with eczema, especially atopic eczema. Apart from its emollient properties, Emulsiderm therefore also helps to prevent and overcome secondary infection which may exacerbate the atopic condition.

No special information.

Sorbitan Stearate; Polysorbate 60; Industrial Methylated Spirit 95%; Methylthioninium Chloride; Purified Water.

None known.

36 months.

Do not store above 25°C. Always replace the cap after use.

Supplied in plastic bottles; a 300 ml bottle with a measuring cap, and a 1 litre bottle with a measuring cup.

No special requirements.

Dermal Laboratories Limited

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

PA 278/8/1.

21 February 2009.

June 2009.