- Approval Id
- ea10167191cdf6b3
- Drug Approval Emc Name
- Fuller's Earth Cream
- Drug Name
- Fuller's Earth Cream
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Atc Code
- D11AX
- Legal Category
- General Sales List
- Authorisation Holder
- Thornton & Ross LtdLinthwaite LaboratoriesHuddersfieldHD7 5QH
- Authorisation Number
- PL 00240/5082R
- Authorisation Date
- 09/01/1987 / 18/07/2006
- Instruction Authorisation Holder
- Thornton & Ross LtdLinthwaite LaboratoriesHuddersfieldHD7 5QH
- Instruction Authorisation Number
- PL 00240/5082R
- Instruction Authorisation Date
- 09/01/1987 / 18/07/2006
- Instruction Composition
- | | |
| --- | --- |
| Heavy Kaolin | 20.76% w/w |
| Zinc oxide | 4.5% w/w |
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- OintmentAn off-white cream of uniform consistency free from foreign matter.
- Instruction 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 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.
- Instruction Pharmacology
- 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.
- Instruction Pharmaceutical Particulars
- 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.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Heavy Kaolin | 20.76% w/w |
| Zinc oxide | 4.5% w/w |
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
OintmentAn off-white cream of uniform consistency free from foreign matter.
## 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 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
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
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.
- Company Detail Path
- /organization/thornton-and-ross-ltd
