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:

Ecolab Healthcare Division

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 Calamine Cream BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 4.0% w/w and Zinc Oxide 3.0% w/w
Excipient(s) with specified warnings
Cetostearyl alcohol 4.0% w/w
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of the symptoms of mild sunburn and other minor skin
conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical application.
Adults, elderly and children: apply liberally to dry, clean skin as
required.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep securely closed when not in use.
Keep out of the sight and reach of children.
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.
Ingredients with specified warnings
This
medicine
contains
Cetostearyl
alcohol
which
may
cause
local
skin
reactions (e.g. contact dermatitis).
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
May mask x-ray pictures under certain circumstances.
4.6
FERTILITY, PREGNANCY AND LACTATION
No information is available on the use of this product during
pregnancy and
lactation. However, it is unlikely that its use would cause any
adverse effects.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known
4.8
UNDESIRABLE EFFECTS
Occasional hypersensitivity or irritant reactions
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal
product is important. It allows continued monitoring of the
benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report
any
suspected adverse