Summary of Product Characteristics (SmPC) - Ultrabase
1 NAME OF THE MEDICINAL PRODUCT
Ultrabase
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin 10.0 %w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For general use as:
- an emollient
- 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Additionally, it may be alternated with topical corticosteroids when the latter are being gradually withdrawn, and may be continued alone after complete withdrawal of the topical corticosteroid.
4.2 Posology and method of administration
For topical administration as required.
4.3 Contraindications
Hypersensitivity to any of the components of Ultrabase.
4.4 Special warnings and precautions for use
Ultrabase contains stearyl alcohol which may cause local skin reactions e.g. (contact dermatitis).
Ultrabase contains methyl parahydroxybenzoate (methyl paraben) [E218] and propyl parahydroxybenzoate (propyl paraben) [E216]. These ingredients may cause allergic reactions (possibly delayed).
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.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
None stated.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The Ultrabase cream formulation has good emollient properties.
5.2 Pharmacokinetic properties
None stated.
5.3 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 SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polyoxyl 40 stearate [E431]
Liquid paraffin
Stearyl alcohol
Carbomer
Sodium hydroxide
Methyl parahydroxybenzoate (methyl paraben) [E218] Propyl parahydroxybenzoate (propyl paraben) [E216] Disodium edetate
Purified water
Citrus-rose perfume oil
6.2 Incompatibilities
None known.
6.3 Shelf life
5 years
6.4 Special precautions for storage
Not applicable.
6.5 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 500 g).
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Keep out of the reach of children.
7 MARKETING AUTHORISATION HOLDER
Derma UK Ltd
The Toffee Factory
Lower Steenbergs Yard, Quayside
Ouseburn, Walker Rd
Newcastle upon Tyne
Tyne and Wear NE1 2DF
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 19876/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/08/2011
10 DATE OF REVISION OF THE TEXT
15/05/2019