Emulsifying Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Liquid paraffin; White soft paraffin; Emulsifying wax

Available from:

Ovelle Limited

ATC code:

D02AX

INN (International Name):

Liquid paraffin; White soft paraffin; Emulsifying wax

Dosage:

30%w/w + 50%w/w + 20 percent weight/weight

Pharmaceutical form:

Ointment

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

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emulsifying Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Emulsifying wax
30% w/w
[Cetostearyl Alcohol
Sodium Lauryl Sulphate
Purified Water]
White soft paraffin
50% w/w
Liquid paraffin
20% w/w
3 PHARMACEUTICAL FORM
Ointment.
White semi-opaque ointment with characteristic odour and smooth
texture.
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.
Soap substitute. See patients information sheet.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Cetostearyl alcohol may cause local skin reactions (e.g. contact
dermatitis).
Sodium laurilsulfate (E 487) 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 SLS can vary according to body site,
age and patient population (children, hydration level, skin color and
disease). Patient populations with decreased skin
barrier functions such as in atopic dermatitis are more sensitive to
the irritant properties of SLS.
Adults:
as above
Babies:
as above
Elderly:
as above
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