Nutraplus Cream

1. Name Of The Medicinal Product

Nutraplus Cream

2. Qualitative And Quantitative Composition

Urea 10% w/w

For excipients see section 6.1

3. Pharmaceutical Form

Cream

Smooth white, almost odourless cream (water in oil emulsion).

4. Clinical Particulars

4.1 Therapeutic Indications

An emollient, moisturising and protective cream for the treatment of dry or damaged skin.

4.2 Posology And Method Of Administration

Adults, elderly and children

Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist.

4.3 Contraindications

None

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes. If irritation occurs, discontinue use temporarily.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No known effects. Use at the discretion of the physician or pharmacist.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Urea is a recognised hydrating agent that has been widely used topically to treat dry or damaged skin.

5.2 Pharmacokinetic Properties

Not applicable. Nutraplus is a topical (cutaneous) preparation.

5.3 Preclinical Safety Data

No specific information is presented given the widespread use of topically applied urea on humans over many years.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol monostearate

Octyl palmitate

Myristyl lactate

Mineral oil

Promulgen D (contains Cetearyl alcohol and ceteareth-20)

Propylene glycol

Propyl parahydroxybenzoate (E216)

Methyl parahydroxybenzoate (E218)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Thirty six months.

6.4 Special Precautions For Storage

Do not store above 25^oC.

As with all medicines, Nutraplus Cream should be stored out of the sight and reach of children.

6.5 Nature And Contents Of Container

White, polyethylene tube with a white polypropylene screw cap as the closure.

Pack sizes: 60g and 100g

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts.

WD17 1DS

UK

8. Marketing Authorisation Number(S)

PL 10590/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

4 June 1991

10. Date Of Revision Of The Text

February 2006