Neutrogena Norwegian Formula Dermatological Cream
SUMMARY OF PRODUCT CHARACTERISTICS
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 listed in section 6.1.
Severely broken skin.
4.4. Special warnings and special 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. Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, 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
Post-marketing data:
Adverse drug reactions (ADRs) identified during post-marketing experience with Glycerol are included in the table below, the frequencies are provided according to the following convention:
Very common >1/10 Common >1/100 and <1/10 Uncommon >1/1,000 and <1/100 Rare >1/10,000, and <1/1,000 Very rare <1/10,000
Not known (cannot be estimated from the available data)
Table 1: Adverse Drug Reactions Identified during Post-Marketing Experience with Glycerol by Frequency Category estimated from Spontaneous Reporting Rates
|
Body system |
Incidence |
Reported adverse event |
|
Immune System Disorders |
Not known |
Hypersensitivity reactions |
|
Body system |
Incidence |
Reported adverse event |
|
General Disorders and Administrative Site Conditions |
Not known |
Application site reactions including burning sensation, erythema, pain, pruritus, rash and irritation. Exacerbation of eczema and dry skin. |
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 at: www.mhra.gov.uk/yellowcard
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.
6.1 List of excipients
Purified water Sodium cetostearyl sulfate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sodium sulfate 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
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
PL 08874/0016
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 01 March 2002 Date of latest renewal: 08 July 2004
10 DATE OF REVISION OF THE TEXT
08/06/2016