- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
2. Qualitative and quantitative composition
|White Soft Paraffin||BP||14.5%||w/w|
|Light Liquid Paraffin||PhEur||12.6%||w/w|
3. Pharmaceutical form
A creamSmooth cream, white or practically white with a slight odour.
4. Clinical particulars
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, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.
4.2 Posology and method of administration
PosologyAdults, the elderly, children and infants over the age of 1 month - apply to the affected part two or three times daily.
Method of administrationFor topical administration.
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
If rash develops, use of the product should be discontinued.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.
4.6 Fertility, pregnancy and lactation
PregnancyThere are no or limited amount of data for the use of white soft paraffin, light liquid paraffin and anhydrous lanolin in pregnant women, The safety of E45 Cream in pregnancy and lactation has not been assessed but is thought unlikely to constitute a hazard.
Breast-feedingIt is unknown whether soft paraffin, light liquid paraffin and anhydrous lanolin metabolites are excreted in human milk. The safety of E45 cream in Lactation is thought unlikely to constitute a hazard.
FertilityNo data on human fertility are available.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely. Should this occur, use of the product should be discontinued.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||Frequency||Adverse Events|
|Immune System Disorders||Not known||Hypersensitivity, Dermatitis allergic|
|Skin and Subcutaneous Tissue Disorders||Not known||Acne|
Reporting of Suspected Adverse ReactionsReporting 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
E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required. There have been no reports of over dosage with use of this product.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals; Soft Paraffin and Fat Products ATC Code: D02AC Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
There are no pre-clinical safety data of relevance to the consumer.
6. Pharmaceutical particulars
6.1 List of excipients
Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.
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
Aluminium tubes and polypropylene tubs: 3 years.All other containers: 2 years.
6.4 Special precautions for storage
Store below 25°C for polyethylene tubes and pump pack, made of polypropylene and polyethylene and consisting of a plastic bottle and a pump system with a dip tube. None for aluminium tubes and polypropylene tubs.
6.5 Nature and contents of container
A collapsible aluminium tube, internally lacquered with a membrane seal and plastic screw cap. Pack sizes: 15, 50 or 100 g.(The 100 g tube is for dispensing only. One hundred tubes will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)A polyethylene tube with membrane seal and plastic screw cap. Pack sizes 15 or 50 g.A polypropylene securipot with a white polythene pilfer-proof screw cap. Pack sizes: 125, 350 or 500 g.A white polypropylene jar with a white polyethylene push-on, tamper-evident closure. Pack sizes: 250, 300 or 500 g.((The 500 g jar is for dispensing only. Thirty-six jars will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or polypropylene dispenser having a polythene covered follower plate.Pack sizes: 500 or 900 g.A pump pack made of polypropylene and polyethylene, consisting of a plastic bottle and a pump system with a dip tube. Pack size: 500 g.A pump pack made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500gNot all pack sizes are necessarily marketed.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Reckitt Benckiser Healthcare (UK) Limited Wellcroft RoadSlough,SL1 4AQUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
25th September 1991
10. Date of revision of the text
Forum Health Products Limited
Crown House, 2-8 Gloucester Road, Redhill, Surrey, RH1 1FH
+44 (0) 1737 857701
Customer Care direct line
0500 455 456
+44 (0)1737 857 700
Medical Information Direct Line
0333 200 5345