Reckitt Benckiser Ireland Limited
Summary of Product Characteristics last updated on medicines.ie: 6/12/2016
White Soft Paraffin 14.5% w/w
Light Liquid Paraffin 12.6% w/w
Anhydrous Lanolin 1.0% w/w
White Soft Paraffin
Light Liquid Paraffin
Methyl Hydroxybenzoate (E218)
Propyl Hydroxybenzoate (E216)
For a full list of excipients, see section 6.1.
Smooth white or practically white cream with not more than a slight odour.
4.1 Therapeutic indications
For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, dermatitis, sunburn, the dry stage of eczema and for use as emollient adjunctive therapy in the treatment of dry cases of psoriasis.
4.2 Posology and method of administration
Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily.
Method of administration
For topical application.
Hypersensitivity to white soft paraffin, light liquid paraffin and anhydrous lanolin or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
May cause allergic reactions (possibly delayed), such as local skin reactions. If rash develops, use of the product should be discontinued.
Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard.
4.5 Interaction with other medicinal products and other forms of interaction
The absorption of topical minoxidil can be increased by concurrent topical soft paraffin. This could potentiate the hypotensive effects of vasodilators.
4.6 Fertility, pregnancy and lactation
No effects during pregnancy are anticipated, since systemic exposure to white soft paraffin, liquid paraffin and lanolin is negligible.
As with all medicines, this product should be used with caution during pregnancy.
It is unknown whether white soft paraffin, light liquid paraffin and anhydrous lanolin metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Application of the product to the breast is not recommended during breast feeding.
No data on human fertility are available.
4.7 Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely. Adverse events which have been associated with white soft paraffin, light liquid paraffin and anhydrous lanolin are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Immune System Disorders
Respiratory, Thoracic and Mediastinal Disorders
Skin and Subcutaneous Tissue Disorders
Description of Selected Adverse Reactions
1 May take the form of an allergic rash. Should this occur, use of the product should be discontinued.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org
E45 cream is of low toxicity.
There have been no reports of over dosage with the use of this product.
If accidental ingestion occurs, symptomatic and conservative treatment is required
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals; Emollients and Protectives; Soft Paraffin and Fat Products
ATC Code: D02AC
Anhydrous lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
There are no preclinical safety data of relevance to the consumer.
6.1 List of excipients
sodium cetostearyl sulphate,
methyl hydroxybenzoate (E218),
propyl hydroxybenzoate (E216),
citric acid monohydrate,
Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.
6.3 Shelf life
2 years-Polyethylene tubes
3 years-Aluminium tubes, polypropylene tubs/pots
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
A polyethylene tube with membrane seal and plastic screw cap.
Pack sizes 15 or 50g.
A polypropylene securipot with a white polythene pilfer-proof screw cap.
Pack sizes: 125g, 350g and 500g.
A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or a polypropylene dispenser having a polythene covered follower plate.
Pack sizes: 500 or 900g.
A pump pack, made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g.
Not all pack sizes are necessarily marketed.
6.6 Special precautions for disposal and other handling
No special requirements.
Reckitt Benckiser Ireland Ltd.,
Citywest Business Campus,
Date of first authorisation: 01 April 1977
Date of last renewal: 06 June 2009