Oilatum Junior Flare-Up Bath AdditiveLight liquid paraffin 52.5%w/wBenzalkonium chloride 6.0%w/wTriclosan
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
03-10-2019
Summary of Product characteristics
(SPC)
14-10-2015
Active ingredient:
Benzalkonium chloride; Light liquid paraffin; Triclosan
Available from:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
ATC code:
D02AC
INN (International Name):
Benzalkonium chloride; Light liquid paraffin; Triclosan
Dosage:
52.5%w/w +6.0%w/w +2.0 percent weight/weight
Pharmaceutical form:
Bath additive
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Soft paraffin and fat products
Authorization status:
Marketed
Authorization date:
1989-05-25
Patient Information leaflet
Please read this leaflet before you start to use _Oilatum Junior
Flare-Up_.
If there is anything you do not understand, or if you want more
information
or advice, ask your pharmacist or doctor.
What does _Oilatum Junior Flare-Up_ contain?
_Oilatum Junior Flare-Up_ contains the emollient light liquid paraffin
52.5% w/w
and the antiseptics benzalkonium chloride 6.0% w/w and triclosan 2.0%
w/w.
It also contains acetylated wool alcohols, isopropyl palmitate, oleyl
alcohol
and macrogol lauryl ether.
_Oilatum Junior Flare-Up_ is supplied in bottles containing 150ml bath
additive by the
Product Authorisation Holder:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited,
12 Riverwalk, CityWest Business Campus, Dublin 24, Ireland.
and is made by Stiefel Laboratories (Ireland) Ltd., Finisklin Business
Park, Sligo, Ireland.
What is_ Oilatum Junior Flare-Up_ used for and how does it work?
_Oilatum Junior Flare-Up_ is for treating eczemas when they flare-up
and are at risk of becoming
infected. Using it early can help to reduce the duration and severity
of the
flare-up. You should continue to use the product until the flare-up
subsides.
Before you use _Oilatum Junior Flare-Up _
_Oilatum Junior Flare-Up _may not be right for some people. If the
user is known to be
allergic to any of the ingredients which are listed above then the
product should
not be used.
_Oilatum Junior Flare-Up _is not recommended for babies younger than 6
months.
Do 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.
DFT-01945-
4392354
IMPORTANT
GSK LOC IS RESPONSIBLE TO
APPROVE THE CHANGE
DOCUMENTATION, ARTWORK BRIEF
AND FINAL ARTWORK, ENSURING
THAT IT IS ACCURATE, CONSISTENT
AND COMPLETE.
GSK SDC IS RESPONSIBLE FOR SITE
TECHNICAL REQUIREMENTS AND
PRE-PRESS SUITABILITY.
GSK MARKET IS RESPONSIBLE
TO ADVISE SDC WHEN CHANGES
REQUIRED IMP
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oilatum Junior Flare-Up Bath Additive
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Bath additive
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 Junior Flare-Up should always be diluted with water. It is an
effective cleanser and should not be used with
soap.
Adults and children: In an eight inch bath add 2 capfuls, in a four
inch bath add 1 capful.
Infants: 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.
The preparation should not be applied directly to the skin.
Light liquid paraffin
52.5
%w/w
Benzalkonium chloride
6.0
%w/w
Triclosan
2.0
%w/w
Light liquid paraffin
52.5
%w/w
Benzalkonium chloride
6.0
%w/w
Triclosan
2.0
%w/w
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