Skip to content
SPC Logo

E45 Cream

Last Updated on eMC 07-Sep-2016 View changes  | Forum Health Products Limited Contact details

1. Name of the medicinal product

E45 Cream

2. Qualitative and quantitative composition

Anhydrous Lanolin

 

1.0%

w/w

White Soft Paraffin

BP

14.5%

w/w

Light Liquid Paraffin

PhEur

12.6%

w/w

Excipient(s) with known effect:

Cetyl alcohol

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

For the full list of excipients, see section 6.1

3. Pharmaceutical form

A cream

Smooth 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

Posology

Adults, the elderly, children and infants over the age of 1 month - apply to the affected part two or three times daily.

Method of administration

For topical administration.

4.3 Contraindications

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

Pregnancy

There 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-feeding

It 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.

Fertility

No 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 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

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

Not applicable.

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.

6.2 Incompatibilities

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: 500g

Not all pack sizes are necessarily marketed.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Limited

Wellcroft Road

Slough,

SL1 4AQ

United Kingdom

8. Marketing authorisation number(s)

PL 00063/0404

9. Date of first authorisation/renewal of the authorisation

25th September 1991

10. Date of revision of the text

24/08/2016

Company contact details

Forum Health Products Limited

Company image
Address

Crown House, 2-8 Gloucester Road, Redhill, Surrey, RH1 1FH

Fax

+44 (0) 1737 857701

Customer Care direct line

0500 455 456

Telephone

+44 (0)1737 857 700

Medical Information Direct Line

0333 200 5345

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

lanolin, anhydrous , light liquid paraffin, white soft paraffin

Legal categories

GSL - General Sales List

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue