Aqueous cream

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

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

Disponible depuis:

Mawdsley-Brooks & Company Ltd

Code ATC:

n/a

DCI (Dénomination commune internationale):

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

Dosage:

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

forme pharmaceutique:

Cutaneous cream

Mode d'administration:

Cutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 13020101

Notice patient

100G
_CALAMINE, ZINC OXIDE_
RELIEVES MILD SUNBURN
& OTHER MINOR SKIN
CONDITIONS
_AQUEOUS_
_CALAMINE_
_CREAM_
100G
_AQUEOUS CALAMINE CREAM_
RELIEVES MILD SUNBURN & OTHER MINOR SKIN CONDITIONS
_CALAMINE, ZINC OXIDE_
_CALAMINE, ZINC OXIDE_
_AQUEOUS_
_CALAMINE_
_CREAM_
RELIEVES MILD SUNBURN & OTHER
MINOR SKIN CONDITIONS
READ ALL THE CARTON BEFORE USE.
WHAT THE MEDICINE IS FOR
Aqueous Calamine Cream contains calamine and zinc oxide which have an
astringent
action. The cream has a soothing effect on mild sunburn and other
minor skin conditions.
BEFORE YOU USE THIS MEDICINE
✗
DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD HAVE….
• An ALLERGY to any of the ingredients.
! WARNINGS AND PRECAUTIONS
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.
!
PREGNANT OR BREASTFEEDING
Using Aqueous Calamine Cream during pregnancy and breastfeeding is
unlikely to have
any ill effects when used as directed. If unsure, talk to your doctor
or pharmacist.
!
IF YOU ARE HAVING AN X-RAY, do not apply beforehand as it may affect
the outcome of the
X-ray examination.
!
IMPORTANT INGREDIENT INFORMATION
This medicine contains cetostearyl alcohol which may cause local skin
reactions
(e.g. contact dermatitis).
✓
HOW TO USE THE MEDICINE
Apply the cream to the skin.
ADULTS, THE ELDERLY AND CHILDREN: Apply liberally to dry clean skin as
required.
FOR EXTERNAL USE ONLY.
!
IF YOU ACCIDENTALLY SWALLOW SOME see a doctor straight away. Take the
pack with you to
show which medicine you have swallowed.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
IF YOU GET THESE SIDE EFFECTS STOP USING THE CREAM AND SEE A DOCTOR:
• Allergic/irritant reaction (e.g. skin rash, red or itchy skin)
If you notice any side effects, stop use and tell your doctor or
pharmacist. They

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aqueous Cream BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Emulsifying Ointment BP 30% w/w
White soft paraffin
15% w/w
Liquid paraffin
6.0% w/w
Cetostearyl alcohol
8.1% w/w
This product contains sodium lauryl sulfate 0.9% w/w, see section 4.4.
This product contains cetostearyl alcohol, see section 4.4
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream (Topical Semisolid)
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 the elderly _
To be applied to the skin as required
4.3
CONTRAINDICATIONS
None
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).
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.6
FERTILITY, PREGNANCY AND LACTATION
Can be used during pregnancy and lactation
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known
4.8
UNDESIRABLE EFFECTS
Aqueous cream may be associated with immediate cutaneous reactions
when
used as a leave-on emollient, such as stinging, burning, itching and
redness.
See section 4.4