Emulsiderm Emollient Bath Additive / Cutaneous Emulsion liquid paraffin 25% w/w, isopropyl myristate 25% w/w, benzalkonium chlor

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isopropyl myristate; Liquid paraffin; Benzalkonium chloride

Available from:

Dermal Laboratories Ltd

ATC code:

D02AX

INN (International Name):

Isopropyl myristate; Liquid paraffin; Benzalkonium chloride

Dosage:

25 + 25 + 0.5 percent weight/weight

Pharmaceutical form:

Cutaneous emulsion

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other emollients and protectives

Authorization status:

Marketed

Authorization date:

1982-09-01

Patient Information leaflet

PACKAGE LEAFLET
_Information for the user_
EMULSIDERM
TM EMOLLIENT
BATH ADDITIVE/CUTANEOUS EMULSION
liquid paraffin 25% w/w, isopropyl myristate 25% w/w, benzalkonium
chloride 0.5% w/w
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
IN THIS LEAFLET:
1.
What Emulsiderm Emollient is and what it is used for
2.
Before you use Emulsiderm Emollient
3.
How to use Emulsiderm Emollient
4.
Possible side effects
5.
How to store Emulsiderm Emollient
6.
Further information
7.
General advice on looking after dry skin conditions
1. WHAT EMULSIDERM EMOLLIENT IS AND WHAT IT IS USED FOR
•
Emulsiderm Emollient is an antimicrobial and emollient (softening and
moisturising)
treatment for dry and problem skin.
•
It is for use in two ways:
–
for adding to your bath water
–
as a leave-on application, by application directly to the skin
•
It helps to treat and prevent dry and itchy (pruritic) skin
conditions, especially eczema and
dermatitis.
•
ALL AGE GROUPS can use Emulsiderm Emollient, including babies.
•
There are two types of ACTIVE INGREDIENT in this product:
–
Benzalkonium chloride is an ANTIMICROBIAL. This helps to:
–
combat bacteria present on your skin that can make eczema worse
–
prevent infection caused by scratching itchy skin.
–
Liquid paraffin and isopropyl myristate are EMOLLIENTS which help to;
–
soften, moisturise and protect your skin by trapping moisture in the
skin and restoring the
normal protective function of the skin
–
prevent the skin-drying and irritant effects that can be caused by
washing and bathing and by
the soaps, foaming additives and fragrances used in ordinary skin
cleansing products.
•
This product can be used in addition to any other emollients or
treatments your doctor or
pharmacist may have given or prescribed for you to treat your dry skin
condition.
2. BEFORE YOU USE EMULSIDERM EMOLLIENT
DO NOT USE this product if you a

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2019
CRN009DTX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emulsiderm Emollient Bath Additive / Cutaneous Emulsion liquid
paraffin 25% w/w, isopropyl myristate 25% w/w,
benzalkonium chloride 0.5% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium Chloride
(as Benzalkonium Chloride Solution)
0.5
%w/w
Liquid Paraffin
25.0
%w/w
Isopropyl Myristate
25.0
%w/w
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Bath additive or cutaneous emulsion
Pale green-blue oil-in-water emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the management of dry skin, by rehydration with
antisepsis. Emulsiderm Emollient contains benzalkonium
chloride. Benzalkonium chloride may be useful in preventing
_Staphylococcus aureus_, a pathogen which often complicates
atopic eczema and associated pruritus. Emulsiderm is specially
formulated in a unique emulsion system optimised for
convenient application to the skin, either via the patient's bath
water or directly.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, INCLUDING THE ELDERLY AND CHILDREN:
For use in the bath:
Add 7 to 30 ml Emulsiderm to a bath of warm water (more or less
according to the size of the bath and individual patient
requirements).
Soak for 5 to 10 minutes. Pat dry.
For application to the skin:
Rub a small amount of undiluted emollient into the dry areas of skin
until absorbed.
4.3 CONTRAINDICATIONS
Sensitivity to any of the ingredients.
Health Products Regulatory Authority
17 November 2019
CRN009DTX
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep away from the eyes.
For external use only.
Keep out of the sight and reach of children.
Take care to avoid slipping in the bath.
Instruct patients not to 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
p