Valderma cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Potassium hydroxyquinoline sulfate; Chlorocresol

Saadav alates:

Optima Consumer Health Ltd

ATC kood:

n/a

INN (Rahvusvaheline Nimetus):

Potassium hydroxyquinoline sulfate; Chlorocresol

Annus:

2mg/1gram ; 2mg/1gram

Ravimvorm:

Cutaneous cream

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13100101

Infovoldik

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE
PACKAGING
CARTON – COLLAPSIBLE ALUMINIUM TUBE
1.
NAME OF THE MEDICINAL PRODUCT
Valderma Cream
Potassium Hydroxyquinoline Sulphate, Chlorocresol
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Potassium Hydroxyquinoline Sulphate 0.2 %w/w
Chlorocresol 0.2 %w/w
3.
LIST OF EXCIPIENTS
Hard paraffin
Stearic acid
Technical white oil
Cetostearyl alcohol
Cetyl ester wax
Urea
Sodium lauryl sulphate
Sodium hydroxide
Geraniol
Purified water
4.
PHARMACEUTICAL FORM AND CONTENTS
Cream
15g
30g
45g
60g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Topical use.
Read this carton before use.
Do not discard this carton as it contains important information for
Valderma Cream.
For external use only.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Do not smoke or go near naked flames – risk of severe burns. Fabric
(clothing, bedding, dressings etc)
that has been in contact with this product burns more easily and is a
serious fire hazard. Washing
clothing and bedding may reduce build up but not totally remove it.
FIRE HAZARD. DO NOT SMOKE OR GO NEAR NAKED
FLAMES; CLOTHING & BEDDING WITH THIS PRODUCT
DRIED ON THEM CAN CATCH FIRE EASILY.
8.
EXPIRY DATE
EXP (MM/YYYY)
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Any unused medicinal product should be disposed of in accordance with
local requirements.
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Optima Consumer Health Limited
Concept House
Brackenbeck Road
Bradford
BD7 2LW
UK
12.
MARKETING AUTHORISATION NUMBER(S)
PL 40575/0009
13.
BATCH NUMBER<, DONATION AND PRODUCT CODES>
_ _
BN:
14.
GENERAL CLASSIFICATION FOR SUPPLY
_ _
P
15.
INSTRUCTIONS ON USE
Valderma is an antibacterial cream. It is used for the treatment of
common skin complaints such as
spots

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Valderma Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
% w/w
Potassium Hydroxyquinoline Sulphate
0.2
Chlorocresol
0.2
(equivalent to 0.125% w/w of 8-hydroxyquinoline base)
Excipients with known effects
Cetostearyl alcohol
Sodium Lauryl Sulphate
For the full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of all common minor skin troubles, for example spots
and
pimples.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and Children:
Wash the affected area with warm water and a gentle soap. Rub in the
cream.
There is no indication that dosage need be modified for the elderly.
The
product may be applied freely two or three times a day to the affected
area of
the skin.
Method of administration
Topical
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Instruct patients not to smoke or go near naked flames – risk of
severe burns.
Fabric (clothing, bedding, dressings etc) that has been in contact
with this
product burns more easily and is a serious fire hazard. Washing
clothing and
bedding may reduce product build-up but not totally remove it.
Treatment should be terminated if irritation develops. In the event of
any
irritation of sensitive skin, wash with luke-warm water.
Product labelling
If symptoms persist, consult your doctor. Keep out of the sight and
reach of
children. For external use only.
This medicine contains cetostearyl alcohol which may cause local skin
reactios
(e.g. contact dermatitis)
This medicine contains sodium lauryl sulphate. Sodium lauryl sulphate
may
cause local skin reactions (such as stinging or burning sensation) or
increase
skin reactions caused by other products when applied on the same area.
The thickness of the skin varies considerably according to the body
site and
with age and can be an important factor in the sensitiv