Active substance(s): WHITE SOFT PARAFFIN
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin 10.0 %w/w
For a full list of excipients, see section 6.1
For general use as:
- a diluent for dermatological preparations and
a vehicle for various dermatological medicaments.
Additionally, it may be alternated with topical corticosteroids when the latter
are being gradually withdrawn, and may be continued alone after complete
withdrawal of the topical corticosteroid.
Posology and method of administration
For topical administration as required.
Hypersensitivity to any of the components of Ultrabase.
Special warnings and precautions for use
Ultrabase contains stearyl alcohol which may cause local skin reactions e.g.
Ultrabase contains methyl parahydroxybenzoate (methyl paraben) [E218] and
propyl parahydroxybenzoate (propyl paraben) [E216]. These ingredients may
cause allergic reactions (possibly delayed).
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
Effects on ability to drive and use machines
Hypersensitivity skin reactions including erythema and pruritus.
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 national reporting system in the United
Yellow Card Scheme
The Ultrabase cream formulation has good emollient properties.
Preclinical safety data
There are no preclinical safety data which could be of relevance to the
prescriber and which are not already included in other relevant sections of the
List of excipients
Polyoxyl 40 stearate [E431]
Methyl parahydroxybenzoate (methyl paraben) [E218]
Propyl parahydroxybenzoate (propyl paraben) [E216]
Citrus-rose perfume oil
Special precautions for storage
Nature and contents of container
This product is available in collapsible aluminium tubes (10 g or 50 g)
and polypropylene jars (500 g).
Also available in a polypropylene pump dispenser (500 g) and a pump
dispenser composed of polyethylene and polypropylene (50 g, 200 g or
Not all pack sizes may be marketed.
Special precautions for disposal
Keep out of the reach of children.
MARKETING AUTHORISATION HOLDER
Derma UK Ltd
The Toffee Factory
Lower Steenbergs Yard, Quayside
Ouseburn, Walker Rd
Newcastle upon Tyne
Tyne and Wear NE1 2DF
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT