SCHOLL COMPLETE CORN REMOVAL KIT 40% W/W MEDICATED PLASTERS

Active substance: SALICYLIC ACID

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1.

NAME OF THE MEDICINAL PRODUCT
Scholl Complete Corn Treatment Kit 40% w/w Medicated Plasters

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic acid 40.00%w/w
For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM
Medicated plaster

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the treatment of corns
Topical application to the skin

4.2.

Posology and method of administration
Adults and Children aged 16 years and over
For best results the feet should be washed and dried before use. One medicated disc
should be placed on the corn and covered with a cover plaster. This should be repeated
daily until the corn can be removed. Treatment should not continue for more than two
weeks, except under medical advice.
Then continue to protect the affected area with the corn foam cushion as required.
Should not be used in children under 16 years, except following a doctor’s
recommendation.

4.3.

Contraindications






Not to be used by diabetics or patients or patients with severe circulatory disorders or
suffering from neuropathy, except following a doctor’s prescription or
recommendation.
Not to be used if the corn or surrounding skin is broken or inflamed.
Not to be used in patients who are hypersensitive to salicylic acid (or other NSAIDs)
or to any excipients in section 6.1
Not to be used by pregnant or breastfeeding patients (see section 4.6)

Not suitable for application to face, ano-genital region, or large areas of the body

4.4.

Special warnings and precautions for use
Discontinue use and remove plaster if excessive discomfort or irritation is experienced or
if sensitivity develops.
Do not apply to normal skin.
For external use only.

4.5.

Interactions with other medicinal products and other forms of interaction
None stated.

4.6.

Fertility, pregnancy and lactation
Pregnancy:
There is no data on the use of topical salicylic acid in pregnant women. Therefore the use
of this product during pregnancy is contraindicated.
Breast feeding:
Salicylates should be given with caution to breast-feeding mothers because of the
possible risk of Reye’s syndrome in nursing infants and there is no data on the use of
topical salicylic acid in breast feeding women. Therefore the use of this product during
pregnancy is contraindicated.
Fertility:
There is no information on the effects of topical salicylic acid and fertility

4.7.

Effects on ability to drive and use machines
None stated.

4.8.

Undesirable effects
Local irritation or dermatitis may occur if applied to normal healthy skin surrounding the
corn. This may be controlled by temporarily discontinuing use and by carefully applying
only to the corn when the treatment is resumed.

4.9.

Overdose
Salicylic acid is readily absorbed through the skin, and symptoms of acute systemic
salicylate poisoning have been reported after excessive use. Symptoms include dizziness,
tinnitus, deafness, sweating, nausea and vomiting, headache, and confusion, and may be
controlled by reducing the dosage.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Salicylic acid: keratolytic agent
Pharmacotherapuetic classification (ATC): D11 AF
Pharmacodynamic Effects
Salicylates have analgesic, anti-inflammatory and antipyretic properties much of which is
ascribed to an inhibition of prostaglandin synthesis. However, the relevant
pharmacodynamic effect of salicylic acid for this product is its “keratolytic” action. The
mechanism of this effect has been investigated in animals and in man, and appears to be
due to a lipid modifying effect in the lipid bilayers of the skin rather than a keratolytic
action. It is thought that the salicylic acid increases lipid structure fluidity so allowing
moisture to penetrate into areas surrounding the corn. This in turn leads to a pressure
build up causing the corn to be pushed upwards. It has been suggested that the occlusive
nature of the plaster enhances this effect.

5.2.

Pharmacokinetic properties
Salicylic acid can be absorbed following topical application.

5.3.

Preclinical safety data

No other information relevant to the prescriber other than that already stated in
other sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Polyvinyl Alkyl Ether (Low Molecular Weight)
Polyvinyl Alkyl Ether (High Molecular Weight)
Titanium Dioxide
Liquid Paraffin
4,4’-Thio-Bis (2-Tert-butyl-5-Mehtylphenol)
Red Iron Oxide
Black Iron Oxide

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf Life
3 years unopened.

6.4.

Special precautions for storage
Do not store above 25ºC.

6.5.

Nature and contents of container
Sachet Contents: 6 medicated adhesive plasters mounted onto a silicone backed
paper.
9 foam corn cushions mounted onto a silicone backed paper.

6.6.

Special precautions for disposal and handling
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

1

7 MARKETING AUTHORISATION HOLDER

Scholl Consumer Products Ltd
103-105 Bath Road
Slough
SL1 3UH
UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00587/5015R

2

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/01/2008

10

DATE OF REVISION OF THE TEXT
01/05/2013

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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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