Cetraben emollient cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

White soft paraffin; Liquid paraffin light

Available from:

Waymade Healthcare Plc

INN (International Name):

White soft paraffin; Liquid paraffin light

Dosage:

132mg/1gram ; 105mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 13020100

Patient Information leaflet

PARTICULARS TO APPEAR ON THE OUTER PACKAGING
LABELLING
1.
NAME OF THE MEDICINAL PRODUCT
Cetraben Advance Emollient 10.5 % w/w, 13.2% w/w Cream
Light Liquid Paraffin, White Soft Paraffin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
This product contains 10.5% w/w Light Liquid Paraffin.
This product contains 13.2 % w/w White Soft Paraffin.
3.
LIST OF EXCIPIENTS
Emulsifying wax (Contains Cetostearyl alcohol and Sodium
Laurilsulfate), Cetostearyl
alcohol, Glycerol (E422), Phenoxyethanol, Citric Acid Monohydrate,
Trisodium Citrate
Dihydrate, Purified Water.
4.
PHARMACEUTICAL FORM AND CONTENTS
Cream
1050g
500g
150g
125g
50g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
FOR EXTERNAL USE ONLY. Apply to dry skin areas as often as required
and rub in. If you
accidentally swallow this product, go to your nearest accident and
emergency department.
Read the package leaflet before use.
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 use if you are allergic to any of the ingredients. Mild skin
reactions, such as redness
and rash, have been seen very rarely. Should this occur, use of the
product should be stopped.
In the unlikely event of side-effects, you should talk to your doctor
or pharmacist.
This product contains Cetostearyl alcohol and 0.49% w/w Sodium
laurilsulfate which may
cause local skin reactions (such as stinging or burning sensation) or
increased skin reactions
caused by other products when applied on the same area.
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.
Flash Warning: New safety information – see label
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WA

Summary of Product characteristics

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