Aqueous cream

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Emulsifying wax; White soft paraffin; Liquid paraffin; Phenoxyethanol; Purified water

Tilgjengelig fra:

Sandoz Ltd

ATC-kode:

n/a

INN (International Name):

Emulsifying wax; White soft paraffin; Liquid paraffin; Phenoxyethanol; Purified water

Dosering :

90mg/1gram ; 150mg/1gram ; 60mg/1gram ; 10mg/1gram ; 690mg/1gram

Legemiddelform:

Cutaneous cream

Administreringsrute:

Cutaneous

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 13020101; GTIN: 5015915835017

Informasjon til brukeren

CLIENT:
PROJECT:
ITEM(S):
Almus UK
12452 / UK
Aqueous Cream x 500g
Label
COLOURS USED:
PMS
2613
PMS
108
BLACK
PMS
144
CUTTER
BRAILLE
This scale measures 100mm when artwork is 100%
0
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30
40
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BARCODE NUMBER 5060057402313
SUPPLIER CODE XCHX0
ALMUS CODE A0231/9
REVISED ARTWORK FOR MHRA APPROVAL
VERSION: 9 (BOOTS)
DRAFT ISSUE: 4
REASON FOR CHANGE: Addition of fire hazard warning
SUPPLIER ISSUE DATE: 6.8.2019
A dermatological cream for the symptomatic relief of dry skin.
This non-perfumed emollient cream helps to soothe, soften
and moisturise dry skin conditions. Lanolin Free
500
G
AQUEOUS CREAM B.P.
(Liquid Paraffin, White Soft Paraffin)
XCHX0
Marketing Authorisation Holder: BCM, Nottingham, NG2 3AA
Manufacturer: BCM Ltd., Nottingham, NG2 3AA
A0231/9
AQUEOUS CREAM B.P. 500G
READ ALL OF THIS LABEL FOR FULL INSTRUCTIONS.
USES: For the relief of the symptoms of dry skin conditions and for
use instead of soap
to wash the skin.
BEFORE YOU USE THIS MEDICINE
DO NOT USE:
• IF YOU ARE ALLERGIC to any of the ingredients
You CAN use this medicine if you are pregnant or breastfeeding.
Contains sodium lauryl sulfate and cetostearyl alcohol, both of which
may cause local skin reactions (e.g. stinging and contact dermatitis).
Contains chlorocresol which may cause allergic reactions.
HOW TO USE THIS MEDICINE
Check the tub seal is not broken before first use. If it is, do not
use the cream.
ADULTS AND CHILDREN: Apply to the skin when you need to. For use on
the skin only.
If symptoms do not go away talk to your doctor. If anyone accidentally
swallows some of
the cream talk to a pharmacist or doctor.
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 product build-up but not
totally remove it.
POSSIBLE SIDE EFFECTS
Most people will not have problems, but some may get some of these
• Occasional allergic reactions (e.g. stinging, b

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aqueous Cream B.P.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
% w/w
White Soft Paraffin BP
Liquid Paraffin BP
15.0
6.0
This product contains sodium lauryl sulphate (0.9% w/w), cetostearyl
alcohol and
chlorocresol, see section 4.4.
For a full list of excipients, section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For topical application to the skin:
As an emollient for the symptomatic relief of dry skin conditions.
As a soap-substitute for skin washing
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and elderly:
To be applied to the skin as required.
4.3.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
_Paediatric population _
Aqueous cream contains sodium lauryl sulfate which may cause local
skin reactions
(e.g. stinging and contact dermatitis), particularly in children with
atopic eczema.
An audit of children attending a paediatric dermatology clinic
recorded the proportion
of immediate cutaneous reactions to emollients (defined as one or more
of burning,
stinging, itching and redness developing within 20 minutes of
application). Aqueous
cream
was
the
emollient
used
by
most
(71%),
which
was
associated
with
an
immediate cutaneous reaction in 56% of exposures, compared with 18%
with other
emollients used (details of the other emollients were not reported; _n
_= 100).
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.
The package leaflet/label should include the following information:
Contains sodium lauryl sulfate and cetostearyl alcohol which may cause
local skin
reactions (e.g. stinging and contact dermatitis)
Contains chlorocresol which may cause allerg