Ultrabase (Bayer plc)

1. Name Of The Medicinal Product

Ultrabase®

2. Qualitative And Quantitative Composition

There are no active constituents.

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Additionally, it may be alternated with topical corticosteroids when the latter are being gradually withdrawn, and may be continued alone after complete withdrawal of the topical corticosteroid.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

None stated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable. Ultrabase contains no active ingredients.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ultrabase has no specific active ingredient, but the 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]

White soft paraffin

Liquid paraffin

Stearyl alcohol

Carbomer

Sodium hydroxide

Methyl parahydroxybenzoate (methyl paraben) [E218]

Propyl parahydroxybenzoate (propyl paraben) [E216]

Disodium edentate [E463]

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 polypropylene pump dispensers (500 g).

6.6 Special Precautions For Disposal And Other Handling

Keep out of the reach of children.

7. Marketing Authorisation Holder

Intendis GmbH

Max-Dohrn-Strasse 10

D-10589

Berlin

Germany

8. Marketing Authorisation Number(S)

PL 28428/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

2 June 1972/13 January 2003

10. Date Of Revision Of The Text

29 September 2006