Cetraben cream

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

White soft paraffin; Liquid paraffin light

Disponible depuis:

Thornton & Ross Ltd

DCI (Dénomination commune internationale):

White soft paraffin; Liquid paraffin light

Dosage:

132mg/1gram ; 105mg/1gram

forme pharmaceutique:

Cutaneous cream

Mode d'administration:

Cutaneous

classe:

No Controlled Drug Status

Type d'ordonnance:

Caution - AMP level prescribing advised

Descriptif du produit:

BNF: 13020100; GTIN: 5030451003454 5030451003430 5030451003669 5030451003676

Notice patient

5 011309 042412
92825691908
92825691908
Read all of this label carefully before you start using
this medicine because it contains important
information for you.
USES: Cetraben Protect is a moisturising and
antimicrobial emollient cream, which can also be used
as an alternative to soap. It forms a protective barrier
on the skin and helps to retain moisture in deeper
layers of the skin. This helps to prevent and treat
dryness and itching which are common problems for
people with eczema and dry skin conditions.
The active ingredient, chlorhexidine gluconate, is an
antimicrobial which helps combat germs on the skin
that make certain types of eczema worse.
DIRECTIONS FOR USE:
Do not use if tamper evident collar is broken or
missing at first use. Prime the pump before first use by
depressing fully until cream appears. If the pump
stops working do not dismantle the pack. Re-start by
covering the nozzle, then fully depress the pump
several times to expel air.
CETRABEN PROTECT IS FOR EXTERNAL USE ON THE SKIN ONLY.
Adults, the elderly, infants and children:
FOR APPLICATION TO THE SKIN – apply the cream to the
affected area and smooth into the skin until absorbed.
Repeat as often as required.
FOR USE AS A SOAP SUBSTITUTE – use in place of an
ordinary soap or shower gel. Ensure the water is warm
but not too hot as this can remove your skin’s natural
oils. Pat dry with a soft towel after washing. Avoid
rubbing as this can make dry skin conditions worse.
THIS PRODUCT CONTAINS CETOSTEARYL ALCOHOL WHICH
MAY CAUSE LOCAL SKIN REACTIONS (E.G. CONTACT
DERMATITIS).
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store below 30°C.
ACTIVE INGREDIENT: Chlorhexidine gluconate 1% w/w
(incorporated as Chlorhexidine Gluconate Solution
5% v/w).
ALSO CONTAINS: cetostearyl alcohol, macrogol
cetostearyl ether, isopropyl alcohol, liquid paraffin,
white soft paraffin and water.
MA HOLDER: Genus Pharmaceuticals, Linthwaite,
Huddersfield, HD7 5QH, UK
PL 06831/0242
92825691908
BEFORE YOU USE CETRABEN PROTECT:
DO NOT USE if you are allergic t

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cetraben Advance Emollient Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin 13.2% w/w
Light Liquid Paraffin 10.5% w/w
Excipient(s) with known effect
Emulsifying wax
5.2% w/w
(Containing: Sodium laurilsulfate 0.49% w/w and Cetostearyl alcohol)
Cetostearyl alcohol
6.21% w/w
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream.
A thick white cream with the characteristic odour of paraffin oil.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetraben Advance Emollient Cream is an emollient, moisturising and
protective
cream for the symptomatic relief of red, inflamed, damaged, dry or
chapped skin,
especially when associated with endogenous or exogenous eczema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical administration: Cetraben Advance Emollient Cream should be
applied to the
dry skin areas as often as required and rubbed in.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains Cetostearyl alcohol and 0.49% w/w Sodium
laurilsulfate which
may cause local skin reactions (such as stinging or burning
sensations) or increased
skin reactions caused by other products when applied on the same area.
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 help
reduce product build-up but not totally remove it.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
No special precautions are required.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8
UNDESIRABLE EFFECTS
Very rarely, mild allergic skin reactions including rash and erythema
have been
observed, in which case use of the product should be discontinued.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reportin