Oilatum Cream

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

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26-11-2020

有效成分:

Liquid paraffin light; White soft paraffin

可用日期:

Clonmel Healthcare Ltd

ATC代码:

D02AC

INN(国际名称):

Liquid paraffin light; White soft paraffin

剂量:

6.0 %w/w +15.0 percent weight/weight

药物剂型:

Cream

治疗领域:

Soft paraffin and fat products

授权状态:

Not marketed

授权日期:

2003-03-07

产品特点

                                Health Products Regulatory Authority
25 November 2020
CRN009Z08
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oilatum Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0%
w/w in a cream base.
Excipient(s) with known effect
Benzyl Alcohol 0.5%w/w
Cetostearyl alcohol
Potassium Sorbate
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A white to off white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oilatum Cream is indicated in the treatment of contact dermatitis,
atopic eczema, senile pruritus, ichthyosis and related dry skin
conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oilatum Cream may be used as often as required. Apply to the affected
area and rub in well. It is especially effective after
washing, when the sebum content of the stratum corneum may be depleted
resulting in excessive moisture loss.
Oilatum Cream is suitable for use in adults, children and the elderly.
4.3 CONTRAINDICATIONS
Should not be used in patients with known hypersensitivity to any of
the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Oilatum Cream should be used with caution in patients with a known
sensitivity or allergy to white soft paraffin or light liquid
paraffin or to any of the excipients in the preparation.
Cetostearyl alcohol and potassium sorbate may cause local skin
reactions (e.g. contact dermatitis).
This medicine contains 0.5% w/w benzyl alcohol which may cause
allergic reactions and mild local irritation.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None.
4.6 FERTILITY, PREGNANCY AND LACTATION
FERTILITY
There are no data on the use of topical Oilatum Cream on human
fertility.
PREGNANCY
There are no data on the use of topical Oilatum Cream in pregnant
women. No effects during pregnancy are anticipated, since
systemic exposure to white soft paraffin-light liquid paraffin is low.
Health Products Regulatory Authority
25 November 2020
CRN
                                
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