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Forum Health Products Limited

Forum Health Products Limited, Betchworth House, 57/65 Station Road, Redhill, Surrey, RH1 1DL
Telephone: +44 (0)1737 857 782
Fax: +44 (0) 1737 857701
WWW: http://www.forum.co.uk
Medical Information Direct Line: 0500 455 456
Customer Care direct line: 0500 455 456

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Summary of Product Characteristics last updated on the eMC: 12/10/2011
SPC E45 Cream


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1. Name of the medicinal product

E45 Cream


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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


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3. Pharmaceutical form

A cream


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4. Clinical particulars

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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.


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4.2 Posology and method of administration

For topical application.

Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily.


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

The labelling states:

For external use only.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach of children.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.


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4.6 Pregnancy and lactation

The safety of E45 Cream in pregnancy and lactation has not been assessed but is thought unlikely to constitute a hazard.


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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4.8 Undesirable effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.


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4.9 Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.


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5. Pharmacological properties

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5.1 Pharmacodynamic properties

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

There are no pre-clinical safety data of relevance to the consumer.


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6. Pharmaceutical particulars

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6.1 List of excipients

Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.


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6.2 Incompatibilities

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.


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6.3 Shelf life

Aluminium tubes and polypropylene tubs: 3 years.

All other containers: 2 years.


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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.


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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.


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6.6 Special precautions for disposal and other handling

None.


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7. Marketing authorisation holder

Reckitt Benckiser Healthcare (UK) Limited

Wellcroft Road

Slough,

SL1 4AQ

United Kingdom


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8. Marketing authorisation number(s)

PL 00063/0404


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9. Date of first authorisation/renewal of the authorisation

25th September 1991


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10. Date of revision of the text

07/10/2011


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11 dosimetry

IF APPLICABLE


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12 instructions for preparation of radiopharmaceuticals

IF APPLICABLE



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/21988/SPC/