Hydrobath Emollient

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

No active listed

Available from:

Alliance Pharma (Ireland) Limited

ATC code:

D02AX

INN (International Name):

No active listed

Dosage:

.

Pharmaceutical form:

Bath additive

Therapeutic area:

Other emollients and protectives

Authorization status:

Not marketed

Authorization date:

2006-06-17

Patient Information leaflet

Hydrobath Emollient leaflet ROI005
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROBATH
TM EMOLLIENT
Isopropyl Myristate, Light Liquid Pariffin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hydrobath
TM
Emollient is and what it is used for
2.
What you need to know before you use Hydrobath
TM
Emollient
3.
How to use Hydrobath
TM
Emollient
4.
Possible side effects
5.
How to store Hydrobath
TM
Emollient
6.
Contents of the pack and other information
1.
WHAT HYDROBATH
TM EMOLLIENT IS AND WHAT IT IS USED FOR
Hydrobath Emollient is a bath or shower additive used to treat any
condition in which dry skin is a
feature such as eczema, ichthyosis (hereditary dry skin) and senile
pruritus (itching that may occur in
old age). It can also be used instead of soap. The combination of oils
is designed to relieve itching,
to lubricate and soften the skin and form a film on the skin surface
to reduce moisture loss.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROBATH
TM EMOLLIENT
_ _
DO NOT USE HYDROBATH
TM EMOLLIENT
-
Do not use Hydrobath Emollient if you are allergic (hypersensitive) to
light liquid paraffin,
isopropyl myristate or any of the ingredients listed in section 6.
WARNINGS AND PRECAUTIONS
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.
Take care to avoid slipping in the bath or shower. Avoid contact with
the eyes, in the

Summary of Product characteristics

Health Products Regulatory Authority
26 March 2019
CRN008KJN
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydrobath Emollient
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Liquid Paraffin
37.80
% w/w
Isopropyl Myristate
13.00
% w/w
Iso-octyl Stearate
15.95
% w/w
Laureth 3
11.25
% w/w
Macrogol 7 Glycerol Cocoate
22.00
% w/w
There is no pharmacologically active ingredient.
3 PHARMACEUTICAL FORM
Bath additive
Clear, colourless, water-dispersible bath oil resulting in an emulsion
of dispersed oils together with a homogenised film on the
water surface.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an aid in the management of dry skin conditions such as eczema,
ichthyosis and senile pruritus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Hydrobath Emollient should be used topically and is either added to
water or applied to wet skin.
1. For use in the bath
a) Adults/ Children:
Add 1-3 inner capfuls to an 8 inch bath of water. Soak for 10-15
minutes.
b) Infants:
Add ½ to 2 inner capfuls to a small bath of water.
2. For application to the skin as a sponge bath or in the shower.
Adults and Children:
Pour a small quantity on to a wet sponge or flannel and rub onto wet
skin. Rinse and pat dry.
4.3 CONTRAINDICATIONS
Known sensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep away from eyes. Take care to avoid slipping in the bath/shower.
If there is aggravation of the condition consult the doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
Health Products Regulatory Authority
26 March 2019
CRN008KJN
Page 2 of 3
4.6 FERTILITY, PREGNANCY AND LACTATION
Hydrobath Emollient is not contra-indicated in pregnancy or lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8 UNDESIRABLE EFFECTS
Patients should be advised to take care to avoid slipping in the bath.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the