Nutraplus Cream
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutraplus 10% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 100mg of Urea
Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.8 mg/g, Propyl
parahydroxybenzoate (E216) 0.9 mg/g, Propylene glycol 45mg/g,
Cetearyl alcohol 18.0 mg/g - 22.5 mg/g For the full list of 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, paediatric population and older people
Apply evenly to the dry skin areas two to three times daily, or as directed by the physician or pharmacist.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
4.4
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 Fertility, 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
Nutraplus has no influence on the ability to drive and use machines.
4.8 Undesirable effects
None known.
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
4.9 Overdose
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group:Protectives and emollients.
ATC code: D02 AE01
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
Not applicable.
6.3 Shelf life
3 years.
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
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Galderma (UK) Limited,
Meridien House 69-71 Clarendon Road
Watford
Herts
WD17 IDS UK
8. MARKETING AUTHORISATION NUMBER
PL 10590/0002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
4 June 1991
10 DATE OF REVISION OF THE TEXT
03/10/2013