DERMALO™ BATH EMOLLIENT

Liquid Paraffin 65.0% w/w; Acetylated Wool Alcohols 5.0% w/w.

Bath additive. Dye- and fragrance-free colourless to straw coloured clear oily liquid.

For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.

Adults, including the elderly: Add 15 to 20 ml (1½ to 2 capfuls) to a standard bath of water (8 inch depth). Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Pat dry with a towel. Alternatively, use a similar amount smoothed onto wet skin following a shower. Rinse off thoroughly and pat dry with a towel.

Infants and children: Add 5 to 10 ml (½ to 1 capful) to a small bath or wash basin of water. Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge over the affected areas. Pat dry with a towel.

There is no differentiation between the dosage quantities for the symptomatic relief of the conditions listed.

Sensitivity to any of the ingredients.

Take care not to slip in the bath or shower. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent. Keep out of the reach of children. For external use only.

None known.

The constituents are not percutaneously absorbed or toxic if ingested. There is no evidence of safety of the drug used in pregnancy or lactation, but the active constituents have been in widespread use and in similar preparations for many years without apparent ill consequence.

None known.

Contact sensitivity reactions or mild irritant reactions may occur occasionally. In either case, treatment should be discontinued.

Accidental ingestion may result in a purgative action due to the liquid paraffin and the oily nature of the product. Treat symptomatically. Fluid and electrolyte replacement may be necessary.

For dry skin conditions it is important to use an emollient while bathing. Dermalo Bath Emollient contains 65% Liquid Paraffin and 5% Acetylated Wool Alcohols for their moisturising and skin softening properties, and is specially formulated to facilitate dispersion in bath water or for ease of application after a shower.

The active constituents are not absorbed percutaneously. Pharmacokinetic particulars are thus not relevant.

No relevant information additional to that contained elsewhere in the SPC.

Isopropyl Myristate; Macrogol 3 Lauryl Ether.

None known.

36 months.

Do not store above 25^oC.

500 ml white plastic bottle fitted with a dispensing plug and screw cap. Supplied in original packs (OP).

Not applicable.

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

00173/0182.

29 August 2008.

August 2008.