Carnation Callous Caps 40% w/w Medicated plasters

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Prenos Navodilo za uporabo (PIL)
16-11-2018
Prenos Lastnosti izdelka (SPC)
16-11-2018

Aktivna sestavina:

Salicylic acid

Dostopno od:

Cuxson Gerrard & Company Ltd

Koda artikla:

D11AF

INN (mednarodno ime):

Salicylic acid

Odmerek:

40 percent weight/weight

Farmacevtska oblika:

Medicated plaster

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Wart and anti-corn preparations

Status dovoljenje:

Marketed

Datum dovoljenje:

1983-04-01

Navodilo za uporabo

                                2 M E D I C A T E D P L A S T E R S
OPEN HERE
Manufacturer and Product Authorisation holder Cuxson Gerrard & Co.
Ltd.,
Broadwell Road, Oldbury, West Midlands B69 4BF, England.
Carnation is a registered trade mark.
Manufactured from
sustainable forests
R20257
P. A. No. 229/3/2
Date of Information
October 2018
Carnation Callous Caps
40% w/w Medicated Plasters
Salicylic Acid
Recommended for
the removal of callouses.
Caution
FOR EXTERNAL USE ONLY.
DO NOT USE:-
-
IF YOU ARE DIABETIC
-
if you have a circulatory disorder
-
if skin close to the callous is inflamed
or broken
-
if you are using any other medicated product
to treat your callous
-
for more than 2 weeks
-
to treat more than 2 callouses at a time
-
for any other purpose than the
removal of callouses
-
if you are allergic to Salicylic Acid, NSAIDs
(asprin), adhesive plasters or any of the
ingredients
-
after the expiry date shown
-
on children under 16
-
if you are pregnant or breast feeding
Directions for Use
1. For better adhesion clean and dry the feet.
2. Remove backing paper and position felt ring
over callous.
3. Firmly fix in position. When properly applied
it should not slip or move.
4. Remove after three days and clean away loose
skin. Repeat process if callous has not been
removed.
Do not exceed recommended dose.
Possible Side Effects
While using this product a mild degree of
soreness may be experienced.
Occasionally local irritation or dermatitis
(skin rash) may occur. If this happens remove
the plaster and clean and dry the area.
Do not repeat treatment.
If the condition hasn’t resolved after 2 weeks or
you experience any unwanted effects consult
your pharmacist or doctor.
This includes any possible side effects not listed
on this pack. You can also report side effects
directly via: www.hpra.ie
Ingredients and Storage
Each medicated dressing contains Active
Ingredient 40% Salicylic Acid. Also contains
Refined Arachis Oil
(
Peanut Oil
)
,
Yellow Beeswax, Partially Hydrogenated Wood
Rosin, Vegetable Triglyceride, E124 Ponceau 4R,
E11O Sunset Yellow.
                                
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Lastnosti izdelka

                                Health Products Regulatory Authority
15 November 2018
CRN008K10
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carnation Callous Caps 40% w/w Medicated plasters
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid 40% w/w.
Also contains Arachis oil (refined), 11.6% w/w per plaster
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Medicated plaster
Dressing with a centre ring containing a paste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the removal of callouses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One medicated dressing to be applied every three days. Estimated
treatment period
is six days.
Do not use for more than two weeks except after medical advice.
DOSAGE
ADULT AND ELDERLY:
Treatment comprises 2 medicated dressings for topical application. A
medicated
dressing is placed over the callous and left in place for 3 days and
then removed.
The area is cleaned to remove the loose skin. The second medicated
dressing may
then be applied if the callous has not been completely removed.
CHILDREN:
Children under 16 years should seek medical advice before use.
Health Products Regulatory Authority
15 November 2018
CRN008K10
Page 2 of 5
4.3 CONTRAINDICATIONS
a) Not to be used by diabetics or patients with severe circulatory
disorders, except
following a doctor's permission or recommendation.
b) Do not use if callous or surrounding skin is inflamed or broken.
c) Do not use if hypersensitive to Salicylic Acid, any of the
components of the
preparation or other NSAIDs due to the risk of cross reactivity.
d) Contains Arachis oil (Peanut oil) and should not be 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
using this product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
a) Discontinue use and remove dressing if excess discomfort or
irritation is
experienced or if sensitivity develops.
b) Do not apply to normal skin or use for 
                                
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