E45 Cream White Soft Paraffin 14.5% w/w Light Liquid Paraffin 12.6% w/w Anhydrous Lanolin 1.0% w/w

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

White soft paraffin; Light liquid paraffin; Lanolin anhydrous

Commercializzato da:

KARO PHARMA AB

Codice ATC:

D02AX

INN (Nome Internazionale):

White soft paraffin; Light liquid paraffin; Lanolin anhydrous

Forma farmaceutica:

Cream

Area terapeutica:

Other emollients and protectives

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1977-04-01

Scheda tecnica

Health Products Regulatory Authority
30 September 2022
CRN00CVF9
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
E45 Cream White Soft Paraffin 14.5% w/w Light Liquid Paraffin 12.6%
w/w Anhydrous Lanolin 1.0% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White soft paraffin
14.5 % w/w
Light liquid paraffin
12.6 % w/w
Anhydrous lanolin
1.0 % w/w
Also contains:
Cetyl alcohol
0.5% w/w
Methyl Hydroxybenzoate (E218)
0.15% w/w
Proryl Hydroxybenzoate (E216)
0.04% w/w
3 PHARMACEUTICAL FORM
Cream
Smooth white or practically white cream with not more than a slight
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of dry skin conditions, where the use of an
emollient is indicated, such as flaking, chapped skin,
ichthyosis, dermatitis, sunburn, the dry stage of eczema and for the
use as emollient adjunctive therapy in the treatment of dry
cases of psoriasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults, Children, Babies and the Elderly - Apply to the affected part
two or three times daily.
METHOD OF ADMINISTRATION
For topical application.
4.3 CONTRAINDICATIONS
Hypersensitivity to white soft paraffin, light liquid paraffin and
anhydrous lanolin or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
If hypersensitivity occurs, such as a rash, use of the product should
be discontinued.
May cause allergic reactions (possibly delayed), such as local skin
reactions. If rash develops, use of the product should be
discontinued.
Patients being dispensed or treated with large quantities (>100g) of
any paraffin-based product should be advised to regularly
change clothing, bedding or dressings impregnated with the product and
keep away from naked flames as there is a fire
hazard, and as such should avoid smoking.
The product should not be applied to the mucous membranes or to broken
skin.
Health Products Regulatory Authority
30 September 2022
CRN00CVF9
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDIC