What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.


Dermalo Bath Emollient

PACKAGE LEAFLET

Information for the user

DermaloTM Bath Emollient

liquid paraffin 65% w/w, acetylated wool alcohols 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 Dermalo Bath Emollient is and what it is used for
2. Before you use Dermalo Bath Emollient
3. How to use Dermalo Bath Emollient
4. Possible side effects
5. How to store Dermalo Bath Emollient
6. Further information
7. General advice on looking after dry skin conditions

1. WHAT DERMALO BATH EMOLLIENT IS AND WHAT IT IS USED FOR

  • Dermalo Bath Emollient is a treatment for dry and problem skin.
  • It is for use in two ways:
    • for adding to your bath water when bathing, or
    • if you normally shower, for smoothing directly onto wet skin and rinsing off.
  • It helps treat dry or chapped skin conditions that may also be itchy, red and sore.
    Common examples include:
    • 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 Dermalo Bath Emollient, including babies.
  • The active ingredients in this product are liquid paraffin and acetylated wool alcohols. These are known as emollients. When used as part of your bathing routine, 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 washing and bathing and by the soaps, foaming additives and fragrances used in ordinary bathing / showering 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 DERMALO BATH EMOLLIENT

Do not use this product if you are allergic (hypersensitive) to liquid paraffin, acetylated wool alcohols, or any of the other ingredients of Dermalo Bath Emollient listed in Section 6.

Take special care when using this product:

  • It can make your bath slippery, so be careful to avoid slipping over when getting into and out of your bath. Be careful when handling babies and young children.
  • After use, clean out the bath with a suitable detergent to remove any remaining greasiness (wearing protective gloves to avoid irritating your hands).

Using other medicines

This product is not known to affect, or to be affected by, other medicines.

Pregnancy and breast-feeding

This product can be used during pregnancy and whilst breast-feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.

3. HOW TO USE DERMALO BATH EMOLLIENT

For maximum benefit you should use this product whenever you bath or shower.

For bathing:

Adults, older children and the elderly:

  • Add approximately 15 to 20 ml (1½ to 2 capfuls) to a normal sized bath filled with water to a depth of roughly 20 cm (8 inches).
  • Get into the bath and cover the affected areas of skin with the bath water.
  • Soak for 10 to 20 minutes.
  • Pat the skin dry with a soft towel.
  • Avoid rubbing with the towel because this makes dry skin conditions worse.

Babies and young children:

  • Add approximately 5 to 10 ml (½ to 1 capful) to a small bath of warm water or wash basin.
  • Submerge the affected areas of skin.
  • Soak for 10 to 20 minutes.
  • Alternatively, repeatedly sponge the water over the affected skin areas.
  • Pat the skin dry with a soft towel.
  • Avoid rubbing with the towel because this makes dry skin conditions worse.

For application to the skin while showering (for all age groups who normally shower):

  • Smooth a similar amount of undiluted product onto wet skin.
  • Rinse off thoroughly.
  • Pat the skin dry with a soft towel.
  • Avoid rubbing with the towel because this makes dry skin conditions worse.

You may prefer to use your normal soap as well as Dermalo Bath Emollient when bathing.

As a general rule, however, the use of normal soaps and foaming bath products (even those labelled “moisturising”) is best avoided, or at least kept to a minimum. Ideally, a fragrance-free soap substitute should be used instead, despite the fact that this type of product does not foam or lather.

If you forget to use Dermalo Bath Emollient

Do not worry if you occasionally forget to use it, just carry on using the product as described the next time you require it.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dermalo Bath Emollient can cause side effects, although not everybody gets them.

This product has been specially designed for use on dry or problem skin, but in some rare cases it can cause irritant or allergic skin reactions on extremely sensitive skin. These rare effects tend to occur during or soon after the first few uses.

Stop using this bath emollient and tell your doctor or pharmacist:

  • If your skin condition seems to look or feel worse.
  • If any of the side effects become unacceptable, or you notice any other side effects not mentioned in this leaflet.

If you swallow Dermalo Bath Emollient

If this product is accidentally swallowed, its oily ingredients may cause diarrhoea.

If this happens:

  • treat the symptoms as you would deal with any case of diarrhoea.
  • drink plenty of water.
  • do not attempt to cause vomiting.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DERMALO BATH EMOLLIENT

  • Keep out of reach and sight of children.
  • Do not use Dermalo Bath Emollient after the expiry date shown on the bottle. The expiry date refers to the last day of that month.
  • Do not store above 25°C.
  • Always replace the cap after use.

6. FURTHER INFORMATION

What Dermalo Bath Emollient contains:

The active ingredients in this product are liquid paraffin (65% w/w) and acetylated wool alcohols (5% w/w).

The other ingredients are isopropyl myristate and macrogol isotridecyl ether.

What Dermalo Bath Emollient looks like and contents of the pack

  • The product is available in a plastic bottle containing 500 ml. The cap is designed to hold 10 ml of product and can be used to help measure out the required quantity to add to the bath (see Section 3).
  • The product is a colourless to straw-coloured liquid that contains no dye or fragrance.

The Marketing Authorisation holder is

Dermal Laboratories
Hitchin
Herts
SG4 7QR
UK

The Manufacturer is

Aeropak
Viking Road
Great Yarmouth
NR31 ONU
UK

This leaflet was last revised in April 2016.

7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS

  • Emollients help soften, moisturise and protect the skin. They play a central role in the treatment and management of dry skin conditions. For maximum effect, they should be applied regularly and as often as needed.
  • When bathing, try to use warm, not hot, water and avoid staying in the bath for long periods. This could make dry skin conditions worse.
  • Try to avoid using normal soaps or bath additives (even those labelled “moisturising”). This is because they tend to dry and irritate the skin. Avoid using products containing fragrances, as these can also cause skin problems. You should try to use a fragrance-free emollient “soap substitute” instead. This type of product will not foam or lather but will be better for your dry skin condition.
  • Breaking the itch-scratch cycle.
    Some dry skin conditions like eczema and dermatitis are itchy, and can be quite sore. Although scratching relieves the itching for a short while, it further damages the skin. Badly scratched skin easily gets infected. This makes it itchier and the urge to scratch becomes even greater. It is better if scratching can be avoided by reducing the itching. The regular use of emollients or moisturisers can help with this.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Dermalo Bath Emollient, 00173/0182.

This is a service provided by the Royal National Institute of Blind People (RNIB).

DP9/16/1 201425