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ULTRABASE

Active substance(s): WHITE SOFT PARAFFIN / WHITE SOFT PARAFFIN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

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are being gradually withdrawn, and may be continued alone after complete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).

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 national reporting system in the United
Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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
04/09/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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