Summary of Product Characteristics Updated 16-Dec-2019 | Dermal Laboratories Limited
Doublebase Emollient Bath Additive
Liquid paraffin 65.0% w/w
Excipients with known effect:
For the full list of excipients, see Section 6.1.
Dye- and fragrance-free white to off-white mobile liquid.
For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.
Adults, including the elderly:
Shake the bottle to mix contents and add 15 to 20 ml (1½ to 2 inner capfuls) to a standard bath of water (20 cm/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.
Infants and children:
Shake the bottle to mix contents and add 5 to 10 ml (½ to 1 inner 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. 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.
Doublebase Emollient Bath Additive contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
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 constituent has 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.
ATC Code: D02AX - Other emollients
For dry skin conditions it is important to use an emollient while bathing. Doublebase Emollient Bath Additive contains 65% liquid paraffin for its moisturising and skin softening properties, and is specially formulated to disperse in bath water.
The active constituent is not absorbed percutaneously. Pharmacokinetic particulars are thus not relevant.
No relevant information additional to that contained elsewhere in the SPC.
Macrogol cetostearyl ether (cetomacrogol)
50 ml: 24 months
200 ml, 500 ml: 30 months
This medicinal product does not require any special storage conditions.
50, 200, 500, or 1000 ml white high density polyethylene bottle fitted with a polypropylene screw cap.
Not all pack sizes may be marketed.
Diomed Developments Limited
T/A Dermal Laboratories
Hertfordshire SG4 7QR
28 March 2006/Unlimited validity granted for 28 March 2011
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
+44 (0)1462 420 565