- liquid paraffin
- wool alcohols, acetylated
GSL: General Sales Licence
This information is intended for use by health professionals
Dermalo Bath Emollient
Acetylated Wool Alcohols
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 sight and reach of children. For external use only.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
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.
Contact sensitivity reactions or mild irritant reactions may occur occasionally. In either case, treatment should be discontinued.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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.
Macrogol isotridecyl ether
36 months in unopened container.
Do not store above 25°C.
50, 200, 500 or 1000 ml white high density polyethylene bottle fitted with a polyethylene dispensing plug and spigotted polypropylene screw cap.
Supplied in original packs (OP).
Diomed Developments Limited
T/A Dermal Laboratories
14 February 2000 / 29 August 2008 (for 24 February 2007 renewal date, unlimited validity)
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
+44 (0)1462 420 565