Oilatum Junior Flare-Up Bath Additive Light liquid paraffin 52.5% w/w Benzalkonium chloride 6.0% w/w Triclosan

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Light liquid paraffin; Benzalkonium chloride; Triclosan

Available from:

Clonmel Healthcare Ltd

ATC code:

D02AC

INN (International Name):

Light liquid paraffin; Benzalkonium chloride; Triclosan

Dosage:

52.5%w/w +6.0%w/w +2.0 percent weight/weight

Pharmaceutical form:

Bath additive

Therapeutic area:

Soft paraffin and fat products

Authorization status:

Marketed

Authorization date:

1989-05-25

Patient Information leaflet

Page 1 of 3
PACKAGE LEAFLET: INFORMATION FOR THE USER
OILATUM® JUNIOR FLARE-UP BATH ADDITIVE
light liquid paraffin52.5% w/w, benzalkonium
chloride 6.0% w/w, triclosan 2.0% w/w
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Oilatum Junior Flare-Up Bath Additive is and what it is used for
2.
What you need to know before you take Oilatum Junior Flare-Up Bath
Additive
3.
How to use Oilatum Junior Flare-Up Bath Additive
4.
Possible side effects
5.
How to store Oilatum Junior Flare-Up Bath Additive
6.
Contents of the pack and other information
1.
WHAT OILATUM JUNIOR FLARE-UP BATH ADDITIVE IS AND WHAT IT IS USED FOR
Oilatum Junior Flare-Up Bath Additive 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 Bath Additive 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OILATUM JUNIOR FLARE-UP BATH
ADDITIVE
ADDITIVE
Oilatum Junior Flare-Up Bath Additive may not be right for some
people. If the user is known to
be allergic to any of the ingredients of this medicine (listed in
section 6) then the product should
not be used.
Oilatum Junior Flare-Up
Bath

Summary of Product characteristics

Health Products Regulatory Authority
17 June 2021
CRN00C342
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oilatum Junior Flare-Up Bath Additive Light liquid paraffin 52.5% w/w
Benzalkonium chloride 6.0% w/w Triclosan
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light liquid paraffin 52.5 %w/w
Benzalkonium chloride 6.0 %w/w
Triclosan 2.0 %w/w
Excipients with known effect
Acetylated wool alcohol 4.0 %w/w
For the 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
Posology
Oilatum Junior Flare-Up should always be diluted with water. It is an
effective cleanser and should not be used with soap.
Paediatric Population
Not recommended for babies younger than 6 months.
Method of administration
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
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1
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.
Health Products Regulatory Authority
17 June 2021
CRN00C342
Page 2 of 3
This medicinal product contains acetylated wool alcohol which may
cause local skin reactions (e.g. contact dermatitis).
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 Junior Flare-Up in
pregnancy and lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Oilatu