This information is intended for use by health professionals

1. Name of the medicinal product

Fullers Earth Cream

2. Qualitative and quantitative composition

Heavy Kaolin

20.76% w/w

Zinc oxide

4.5% w/w

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Ointment

An off-white cream of uniform consistency free from foreign matter.

4. Clinical particulars
4.1 Therapeutic indications

A soothing and protective cream for the skin.

4.2 Posology and method of administration

Cutaneous use

Recommended dose and dosage schedule

Applied to the skin as required.

This product is suitable for use by adults, children and the elderly.

4.3 Contraindications

Contraindicated in hypersensitivity to arachis oil, wool alcohols or any of the other ingredients.

4.4 Special warnings and precautions for use

For external use only.

Keep all medicines away from children

Fullers Earth Cream contains Arachis Oil (peanut oil) and should not be taken / applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Fullers Earth Cream.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

No adverse effects are considered likely when the product is used in either of the above conditions.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

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

Overdosage is unlikely. If accidentally ingested treatment should be symptomatic.

5. Pharmacological properties
5.1 Pharmacodynamic properties

D11A X – Other dermatologicals

Zinc oxide has mild antiseptic and astringent properties and as such is useful in the treatment of certain cutaneous disorders including eczema and psoriasis.

5.2 Pharmacokinetic properties

No information available.

5.3 Preclinical safety data

None.

6. Pharmaceutical particulars
6.1 List of excipients

Refined arachis oil

Yellow beeswax

Light liquid paraffin

Hard paraffin

Wool alcohols

Yellow soft paraffin

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

60g: amber glass jar, metal cap with steran faced liner.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing authorisation number(s)

PL 00240/5082R

9. Date of first authorisation/renewal of the authorisation

09/01/1987 / 18/07/2006

10. Date of revision of the text

02/01/2015