E45 CreamWhite Soft Paraffin 14.5% w/wLight Liquid Paraffin 12.6% w/wAnhydrous Lanolin 1.0%

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Light liquid paraffin; Lanolin anhydrous; White soft paraffin

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

D02AX

INN (International Name):

Light liquid paraffin; Lanolin anhydrous; White soft paraffin

Dosage:

14.5%w/w +12.6%w/w+1.0 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other emollients and protectives

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

500G Pump Label
DERMATLOGICAL E45 Cream
White Soft Paraffin 14.5% w/w
Light Liquid Paraffin
12.6%
w/w
Anhydrous Lanolin 1.0% w/w
Treatment for DRY Skin Conditions
This pump pack incorporates:

Visibility strip to indicate how much cream is left

Simple twist and lock pump
Effective and pleasant to use, E45 CREAM has been clinically proven to
treat and sooth dry, itching,
flaking, chapped, rough and calloused skin, sunburn and detergent
hands. It’s non-greasy emollient
formulation is quickly absorbed by your skin, leaving it soft
comfortable and relived.
E45 CREAM is recommended for more serious dry skin conditions such as
eczema, dermatitis and
ichthyosis and as an adjunctive therapy in the treatment of psoriasis.
E45 CREAM can be used every day by the whole family including babies.
Also available in 15g, 50g, 125g and 350g*
*Not all pack sizes are necessarily marketed.
Clinically Proven – Perfume Free – Dermatologically Tested –
Allergy Screened
DIRECTIONS: Twist pump to OPEN position. Depress pump to dispense
cream. Twist pump back to
lock. Each actuation of the pump dispenses approx. 4g of cream. Apply
liberally 2 or 3 times daily,
or as required.
For external use only.
Do not use on mucous membranes or broken skin. Consult your doctor or
pharmacists before use if
breast feeding.
Do not use if allergic to any of the active ingredients. Side effects
may include acne, pneumonia
lipoid symptoms including fatigue, fever, night sweats, dry cough and
hypersensitivity possibly taking
the form of an allergic rash.
If you suspect an allergic reaction stop using the product. Patients
being treated with large quantities (>100g)
of any paraffin-based product are advised to
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.
If symptoms persist or anything unusual happens, talk to your

Summary of Product characteristics

Health Products Regulatory Authority
13 December 2021
CRN00CGYV
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
E45 CreamWhite Soft Paraffin 14.5% w/wLight Liquid Paraffin 12.6%
w/wAnhydrous 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
13 December 2021
CRN00CGYV
Page 2 of 4
4.5 INTERACTION WITH OTHER MEDICINAL