Oilatum Plus Bath Additive Light liquid paraffin 52.5% w/w Benzalkonium chloride 6.0% w/w Triclosan 2.0% w/w

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzalkonium chloride; Triclosan; Light liquid paraffin

Available from:

Clonmel Healthcare Ltd

ATC code:

D08AJ; D08AJ01

INN (International Name):

Benzalkonium chloride; Triclosan; Light liquid paraffin

Dosage:

52.5/6/2 percent weight/weight

Pharmaceutical form:

Bath additive

Therapeutic area:

Quaternary ammonium compounds; benzalkonium

Authorization status:

Not marketed

Authorization date:

1989-05-25

Summary of Product characteristics

Health Products Regulatory Authority
04 November 2019
CRN0098VT
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oilatum Plus Bath Additive Light liquid paraffin 52.5% w/w
Benzalkonium chloride 6.0% w/w Triclosan 2.0% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light liquid paraffin
52.5
% w/w
Benzalkonium chloride
6.0
% w/w
Triclosan
2.0
% w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Bath additive.
A clear, pale yellow oily solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of infected eczemas and eczemas at risk from
infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oilatum Plus should always be diluted with water. It is an effective
cleanser and should not be used with soap.
Bath: In an eight inch bath add 2 capfuls; in a four inch bath add 1
capful.
Infant bath: Add 1 ml (just sufficient to cover the bottom of the cap)
and mix well with water.
Soak for 15 minutes, gently pat the skin dry with a clean towel. Use
once daily.
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to any of the ingredients should
not use the product.
Not recommended for babies younger than 6 months.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact of the undiluted product with the eyes.
Take care to avoid slipping in the bath.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
There are no restrictions on the use of Oilatum Plus in pregnancy and
lactation.
Health Products Regulatory Authority
04 November 2019
CRN0098VT
Page 2 of 3
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE EFFECTS
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected
adverse reactions via HPRA Pharmacovigilance, Earlsfo