Neutrogena Norwegian Formula Dermatological Cream

1. Name Of The Medicinal Product

Neutrogena Norwegian Formula Dermatological Cream

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.

3. Pharmaceutical Form

Cream for topical use.

White thick cream

4. Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Posology And Method Of Administration

Apply regularly to the affected area.

4.3 Contraindications

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

Severely broken skin.

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).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

Not relevant

4.8 Undesirable Effects

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

4.9 Overdose

Not applicable.

5. Pharmacological Properties

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.'

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Sodium cetostearyl sulphate

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Sodium sulphate

Dilauryl thiodipropionate

Stearic acid

Cetostearyl alcohol

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

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

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.

7. Marketing Authorisation Holder

Johnson & Johnson Ltd

Foundation Park

Roxborough Way

Maidenhead

Berks

SL6 3UG

8. Marketing Authorisation Number(S)

PL 08874/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 01 March 2002

Date of latest renewal: 08 July 2004

10. Date Of Revision Of The Text

19 August 2008