Aqueous Cream Emulsifying Wax 9% w/w, White Soft Parafin 15% w/w, Liquid Paraffin 6% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Emulsifying wax; White soft paraffin; Liquid paraffin

Available from:

Ovelle Limited

ATC code:

D02AX

INN (International Name):

Emulsifying wax; White soft paraffin; Liquid paraffin

Dosage:

9% w/w + 15% w/w + 6 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:

1988-11-18

Summary of Product characteristics

Health Products Regulatory Authority
09 January 2019
CRN008LPZ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aqueous Cream
Emulsifying Wax 9% w/w, White Soft Parafin 15% w/w, Liquid Paraffin 6%
w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Emulsifying Wax BP 9.0%w/w
White Soft Paraffin BP 15.0%w/w
Liquid Paraffin Ph. Eur. 6.0%w/w
Excipient: Emulsifying wax (containing Cetostearyl alcohol and sodium
lauril sulfate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth white homogenous, light cream with a faint characteristic
odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
a) Moisturiser and emollient that soothes and helps to hydrate dry
skin.
b) Soap substitute.
Eczema and other dry skin conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply as often as required to prevent itching and flaking dry skin.
Adults: as above
Babies: as above
Elderly: as above
4.3 CONTRAINDICATIONS
Not to be used by persons known to be sensitive to the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
09 January 2019
CRN008LPZ
Page 2 of 5
For external use only.
If there is no improvement or aggravation of the conditions occurs,
consult your
doctor. Contains Cetostearyl alcohol which may cause local skin
reactions (e.g.
stinging and contact dermatitis).
Sodium lauril sulfate (E487) may cause local skin reactions (such as
stinging or
burning sensation) or increase skin reactions caused by other products
when applied
on the same area.
Sensitivity to Sodium lauril sulfate (SLS) can vary according to body
site, age and
patient population as well as other factors such as hydration level,
skin colour and
disease. Patient populations with decreased skin barrier functions
such as in atopic
dermatitis are more sensitive to the irritant properties of SLS.
Paediatric population
Aqueous cream contains sodium lauril sulfate (E487) which may cause
local skin
reactions (e.g. stinging and contact dermatitis), particularly in
childr