E45 CREAM

Active substance: WOOL FAT

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
E45 Cream

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous Lanolin
White Soft Paraffin
Light Liquid Paraffin

3

BP
PhEur

1.0%
14.5%
12.6%

w/w
w/w
w/w

PHARMACEUTICAL FORM
A cream

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

4.3

Contraindications
Hypersensitivity to any of the ingredients.

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.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.

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.

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, but should they occur, may take the form of an allergic rash.
Should this occur, use of the product should be discontinued.

4.9

Overdose

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

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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
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
07/10/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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