DERMOL™ 600 BATH EMOLLIENT

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

White bath additive.

An antimicrobial bath emollient for use as an aid in the treatment of dry and pruritic skin conditions, especially eczema, dermatitis, ichthyosis or xeroderma. It permits the rehydration of the keratin by replacing lost lipids, and its antiseptic properties assist in overcoming secondary infection.

For use in the bath: For adults, children and the elderly: Add up to 30 ml to a bath of warm water (more or less according to the size of the bath and individual patient requirements). For infants: Add up to 15ml to a bath of warm water (more or less according to the size of the bath and individual patient requirements). Soak for 5 to 10 minutes. Pat dry.

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 special precautions.

None known.

Although the bath 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 in nature.

Not applicable.

For dry skin conditions it is important to add an emollient to the bath water. Dermol 600 Bath Emollient contains 50% of oils emulsified in water as well as the well-known antiseptic, benzalkonium chloride which assists in overcoming secondary infection.

Dermol 600 Bath Emollient 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, 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, Dermol 600 Bath Emollient therefore also helps to prevent and overcome secondary infection which may exacerbate the eczematous condition.

The safety and efficacy of the emollients (liquid paraffin and isopropyl myristate) and the antiseptic (benzalkonium chloride) in topical dosage forms have been well established over many years of widespread clinical usage.

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

None known.

36 months.

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

600 ml plastic bottle with a measuring cap.

Not applicable.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

00173/0155.

13 July 2009.

July 2009.