Seal and Heal Verruca Removal Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAMPHOR, SALICYLIC ACID

Available from:

Scholl Consumer Products Limited 103 - 105 Bath Road Slough, SL1 3UK, United Kingdom

ATC code:

D11AF

INN (International Name):

CAMPHOR 3.11 % (W/W) SALICYLIC ACID 12.5 % (W/W)

Pharmaceutical form:

CUTANEOUS SOLUTION

Composition:

CAMPHOR 3.11 % (W/W) SALICYLIC ACID 12.5 % (W/W)

Prescription type:

OTC

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-08-29

Patient Information leaflet

Reckitt Benckiser
0006 PL00587-5003 RFI variation
1.3.2 Mock-up
Scholl Seal and Heal Verruca Removal Gel NP 12.5% w/w + 3.11% w/w
S0010081
Page 1

Summary of Product characteristics

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Scholl Corn and Callous Removal Liquid
Scholl Medicated Corn and Callous Removal Liquid
Seal and Heal Verruca Removal Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENT
% W/W
Salicylic Acid EP
12.50
Camphor BP
3.11
3
PHARMACEUTICAL FORM
Topical solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
the
treatment
of
corns,
calluses,
common
warts
and
plantar
warts
(verrucas).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS
For best results the feet should be washed and dried before use. The
healthy
skin around the area to treat should be protected with soft paraffin.
The
product should be applied directly to the wart, verruca, callous or
corn twice a
day, until the wart, verruca callous or corn has been removed.
Treatment may
be continued for up to twelve weeks except on medical advice.
No distinction is made between different categories of patient.
CHILDREN
Not recommended for children under twelve, except following a
doctor’s
recommendation.
4.3
CONTRAINDICATIONS
Not to be used by diabetics or those with severe circulatory disorders
or
suffering
from
neuropathy,
except
following
a
doctor’s
permission
and
recommendation.
Not to be used in patients who are hypersensitive to salicylic acid
(or other
NSAIDs), camphor or to any excipients in section 6.1.
Page 2 of 6
Not to be used if the corn, callous, wart, verruca or surrounding skin
is broken
or inflamed.
Not to be used by pregnant or breastfeeding patients (see section 4.6)
When indicated for the treatment of warts and verruca, the product
must not be
used on moles, birthmarks, hairy or genital warts. It must not be used
on the
face or anogenital skin, mucosa or large areas of the body.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Discontinue
use
and
remove
any
dressing
if
excessive
discomfort
is
experienced.
If the liquid comes into contact with normal skin wash off immediately
with
copious water.
Do not apply to normal skin.
For external