Fuller's Earth Cream
Marketing Authorization Holder: Thornton & Ross LtdLinthwaite LaboratoriesHuddersfieldHD7 5QH
General Sales List
D11AX
PL 00240/5082R
Summary of Product Characteristics
Detailed prescribing information and pharmaceutical guidance from the UK Electronic Medicines Compendium.
Composition
Active and inactive ingredients
| | | | --- | --- | | Heavy Kaolin | 20.76% w/w | | Zinc oxide | 4.5% w/w | For the full list of excipients, see section 6.1.
Pharmaceutical Form
Dosage form and administration route
OintmentAn off-white cream of uniform consistency free from foreign matter.
Clinical Particulars
Therapeutic indications and usage
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 childrenFullers 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.
Pharmacological Properties
Pharmacodynamics and pharmacokinetics
5.1 Pharmacodynamic properties D11A X Other dermatologicalsZinc 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.
Pharmaceutical Particulars
Storage and handling information
6.1 List of excipients Refined arachis oilYellow beeswaxLight liquid paraffinHard paraffinWool alcoholsYellow soft paraffin6.2 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.