Fullers Earth cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zinc oxide; Kaolin heavy

Available from:

Thornton & Ross Ltd

ATC code:

n/a

INN (International Name):

Zinc oxide; Kaolin heavy

Dosage:

45mg/1gram ; 207.6mg/1gram

Pharmaceutical form:

Cutaneous ointment

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020100; GTIN: 5011309033519

Patient Information leaflet

PAGE 3
CARE FULLER’S EARTH CREAM
PAGE 1
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Summary of Product characteristics

OBJECT 1
FULLER'S EARTH CREAM
Summary of Product Characteristics Updated 12-Jan-2015 | Thornton &
Ross Ltd
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