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Johnson & Johnson Ltd

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG, UK
Telephone: +44 (0)1628 822 222
Medical Information Direct Line: +44 (0)1344 864 042
Medical Information e-mail: medinfo@congb.jnj.com

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Summary of Product Characteristics last updated on the eMC: 15/10/2008
SPC Neutrogena Norwegian Formula Dermatological Cream


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1. NAME OF THE MEDICINAL PRODUCT

Neutrogena Norwegian Formula Dermatological Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

The cream contains Glycerol Ph. Eur. 40% w/w as the active ingredient.

For a full list of excipients see section 6.1.


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3. PHARMACEUTICAL FORM

Cream for topical use.

White thick cream


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the management of dry skin problems associated with eczema, psoriasis, dermatitis, ichthyosis and winter dry skin.


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4.2 Posology and method of administration

Apply regularly to the affected area.


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4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Severely broken skin.


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4.4 Special warnings and precautions for use

Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).

Contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).


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4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.


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4.6 Pregnancy and lactation

No limitation on the use of Neutrogena Norwegian Formula Dermatological Cream is imposed by pregnancy or lactation.


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4.7 Effects on ability to drive and use machines

Not relevant


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4.8 Undesirable effects

Itching, rash, irritation, dry skin, burning, pain and exacerbation of eczema are very rare (less than 1/10,000)


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4.9 Overdose

Not applicable.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Emollient and protective ATC code: D02AX.

The exact nature of the mechanism of action of glycerol is not clear but is probably due to its hygroscopic action which can enhance moisture retention.'


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5.2 Pharmacokinetic properties

Not applicable


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5.3 Preclinical safety data

Not applicable


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Purified water

Sodium cetostearyl sulphate

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Sodium sulphate

Dilauryl thiodipropionate

Stearic acid

Cetostearyl alcohol


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6.2 Incompatibilities

Not applicable


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Do not store above 25°C


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6.5 Nature and contents of container

Low density polyethylene tubes with screw cap containing 100 ml cream.


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6.6 Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.


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7. MARKETING AUTHORISATION HOLDER

Johnson & Johnson Ltd

Foundation Park

Roxborough Way

Maidenhead

Berks

SL6 3UG


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8. MARKETING AUTHORISATION NUMBER(S)

PL 08874/0016


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01 March 2002

Date of latest renewal: 08 July 2004


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10. DATE OF REVISION OF THE TEXT

19 August 2008



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/20919/SPC/


Active Ingredients/Generics

 
   glycerol