N
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 25oC.
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
Nutraplus Cream
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