Doublebase emollient bath additive

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Liquid paraffin

Commercializzato da:

Dermal Laboratories Ltd

INN (Nome Internazionale):

Liquid paraffin

Dosaggio:

650mg/1gram

Forma farmaceutica:

Bath additive

Via di somministrazione:

Cutaneous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 13020101; GTIN: 5016379194009

Foglio illustrativo

PACKAGE LEAFLET
_Information for the user_
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, nurse or pharmacist if you need more information or
advice.
IN THIS LEAFLET:
1. What Doublebase Emollient Bath Additive is and what it is used for
2. Before you use Doublebase Emollient Bath Additive
3. How to use Doublebase Emollient Bath Additive
4. Possible side effects
5. How to store Doublebase Emollient Bath Additive
6. Further information
7. General advice on looking after dry skin conditions
1. WHAT DOUBLEBASE EMOLLIENT BATH ADDITIVE IS AND WHAT IT IS
USED FOR
•
Doublebase Emollient Bath Additive is a skin treatment for you to add
to your bath
water when bathing.
•
It helps treat dry or chapped skin conditions that may also be itchy,
red and sore.
Common examples include:
– psoriasis (scaly, pink patches of skin), elderly pruritus (itchy
skin due to ageing),
ichthyosis (abnormal scaly skin), various forms of eczema, dermatitis
and other
dry skin disorders.
• ALL AGE GROUPS can use Doublebase Emollient Bath Additive, including
babies.
•
The ACTIVE INGREDIENT in this product is liquid paraffin. This active
ingredient is an
EMOLLIENT. When added to your bath water the product helps 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
bathing and by the
soaps, foaming additives and fragrances used in ordinary bath
products.
•
This product can be used in addition to any other emollients or
treatments your doctor,
pharmacist or nurse may have given or prescribed for you to treat your
dry skin condition.
2. BEFORE YOU USE DOUBLEBASE
EMOLLIENT
BATH ADDITIVE
DO NOT USE Doublebase Emollient Bath Additive if you are ALLERGIC
(hypersensitive) to liquid
paraffin or any of the other ingredients of Doublebase Emollient Bath
Additive listed in
Section 6.
WARNINGS AND

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doublebase Emollient Bath Additive.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid paraffin 65.0% w/w
Excipients with known effect:
Cetostearyl alcohol
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Bath additive. Dye- and fragrance-free white to off white mobile
liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of contact dermatitis, atopic dermatitis,
senile pruritus,
ichthyosis and related dry skin disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, including the elderly:
Shake the bottle to mix contents and add 15 to 20 ml (1½ to 2 inner
capfuls) to a
standard bath of water (20 cm depth). Immerse and cover the affected
areas with the
bath water and soak for 10 to 20 minutes. Pat dry with a towel.
Infants and children:
Shake the bottle to mix contents and add 5 to 10 ml (½ to 1 inner
capful) to a small
bath or wash basin of water. Immerse and cover the affected areas with
the bath water
and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge
over the
affected areas. Pat dry with a towel.
There is no differentiation between the dosage quantities for the
symptomatic relief of
the conditions listed.
4.3
CONTRAINDICATIONS
Sensitivity to any of the ingredients
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Take care not to slip in the bath. Surfaces that have been in contact
with the product
should be cleaned with a proprietary detergent. Keep out of the sight
and reach of
children. For external use only.
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
product build-up but not totally remove it.
Doublebase Emollient Bath Additive contains cetostearyl alcohol which
may cause
local skin reactions (e.g. contact dermatitis).
4.5
INTERACTION WITH OTHER MEDICINAL PRODU