information for the user

DermOl

US

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 Dermol Wash is and what it is used for

2.    Before you use Dermol Wash

3.    How to use Dermol Wash

4.    Possible side effects

5.    How to store Dermol Wash

6.    Further information

7.    General advice on looking after dry skin conditions

1.    WHAT DERMOL WASH IS AND WHAT IT IS USED FOR

•    Dermol Wash is a moisturising, protective and antiseptic soap substitute for you to use whenever you wash. It has been developed for use instead of soaps (bars and liquids) and cleansers, both of which may irritate dry skin.

•    Dermol Wash can also be used as a leave on treatment, re-applied after washing and drying.

•    It helps treat and prevent dry and itchy skin conditions. Common examples include;

-    occupational hand dermatitis (due to frequent hand-washing, or repeated contact with water or chemicals such as cleaning or hair products)

-    eczema and other types of dermatitis

-    psoriasis (scaly, pink patches of skin)

-    elderly pruritus (itchy skin due to ageing)

-    ichthyosis (unusually scaly skin)

•    All age groups can use Dermol Wash, including babies.

•    The active ingredients in this product are isopropyl myristate and liquid paraffin (which are emollients), and benzalkonium chloride and chlorhexidine dihydrochloride (which are antimicrobials).

•    This soap substitute is specially designed to be non-foaming and is fragrance free. When used as part of your normal washing routine, it helps to:

-    cleanse, soften, moisturise and protect your skin by trapping in moisture and restoring the normal protective function of the skin

-    prevent the skin-drying and irritant effects that can be caused by washing and by the soaps, foaming additives and fragrances used in ordinary cleansing products

-    combat bacteria present on your skin that can make eczema worse

-    prevent infection caused by scratching itchy skin

-    prevent ‘flare-ups’ of your skin condition

•    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 DERMOL WASH

Do not use Dermol Wash if you are allergic (hypersensitive) to isopropyl myristate, liquid paraffin, benzalkonium chloride and chlorhexidine dihydrochloride or any of the other ingredients of Dermol Wash listed in Section 6.

Special warnings and precautions

As with any product, severe generalised allergic reactions (see Section 4) are possible. Very rare reports of such reactions in susceptible individuals, leading to a drop in blood pressure and even to unconsciousness, have been associated with products containing chlorhexidine. You must not use Dermol Wash if you have had problems with chlorhexidine-containing products in the past. Take care when using this product:

•    Avoid getting it in the eyes, especially when using it on the face.

•    I f you decide to use this product to wash with in the bath or shower, it can make the surface slippery, so:

-    be careful to avoid slipping over when getting into and out of your shower or bath (eg by using a shower or bath mat);

-    after use, clean out the bath/shower tray with a suitable detergent to remove any remaining greasiness (wearing protective gloves to avoid irritating your hands).

•    For patients with very sensitive skin, it is generally a good idea to start any new treatment on a small test area first, in case any side effect occurs (see Section 4 overleaf). This is especially important when treating the face or young children. Thereafter, treatments may be applied more generously, as required.

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.

Information about the ingredients of Dermol Wash

If you have previously experienced local skin reactions (e.g. contact dermatitis) to any of the ingredients, please talk to your doctor before using this product. Problems of this sort are possible with any ingredient, and a small number of people are known to be sensitive to cetostearyl alcohol in particular.

3.    HOW TO USE DERMOL WASH

This product is only for application to the skin. Use this product as part of your normal washing routine, instead of your ordinary soap (bar or liquid) or cleanser. For maximum benefit you should use it whenever you wash (including routine hand washing).

Before using this product, turn the top of the pump dispenser anti-clockwise to unlock it. After unlocking, you will need to press down the pump dispenser several times to prime the pump before any product is dispensed.

•    Wash with this product in the same way as you would with any liquid soap.

•    Use it with a gentle washing action. The product will not foam or lather as you wash.

•    Rinse off (you should still be able to feel the product coating the skin).

•    Pat the skin dry with a soft towel (avoid rubbing as this can make dry skin conditions worse).

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You can also use Dermol Wash as a leave-on treatment, by re-applying it after washing and drying.

•    Gently smooth the product into the dry skin areas. If necessary, allow time for any excess to soak in. Do not rub the skin vigorously.

•    I f you are applying another product to the same areas of skin as Dermol Wash, try to avoid mixing the two products. You can do this by applying the treatments alternately, leaving enough time to allow the previous product to soak in.

Dermol Wash can be used for intensive and frequent hand-washing (e.g. for healthcare professionals in a clinical setting).

•    Using Dermol Wash, follow the hand-washing technique normally recommended.

•    Rinse thoroughly and dry.

•    Apply Dermol Wash to hands as a leave-on skin conditioner.

If you forget to use Dermol Wash

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

If the product gets Into the eyes

The product may cause irritation if it gets into the eyes. Rinse the eyes with plenty of water.

If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, seek medical advice.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Dermol Wash can cause side effects, although not everybody gets them.

If you experience any of the following reactions stop using Dermol Wash and get urgent medical help: swelling of the face, lips, tongue or throat; a sudden uncharacteristic red itchy skin rash (hives) away from the site of application; wheezing or breathing difficulty; feeling faint or dizzy; a strange metallic taste in the mouth; or collapse. You may be having a serious allergic reaction.

This product has been specially designed for use on dry or problem skin areas anywhere on the body. Rarely, Dermol Wash can cause skin reactions on treated areas (involving redness, irritation and/or itching). These very rare skin reactions may become more significant where associated with excessive use as a leave-on application in areas of folded skin such as the groin or in the nappy area.

Stop using this product and tell your doctor, nurse or pharmacist:

•    I f your skin condition seems to look or feel worse.

•    I f any of the side effects become unacceptable, or you notice any other side effects not mentioned in this leaflet.

If you swallow Dermol Wash

If you accidentally swallow the product and you then feel unwell, seek medical attention.

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 provide more information on the safety of this medicine.

5.    HOW TO STORE DERMOL WASH

•    Keep out of reach and sight of children.

•    Do not use Dermol Wash after the expiry date shown on the container and carton.

The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    After using the product it is advisable to turn the top of the pump dispenser clockwise to lock it.

6.    FURTHER INFORMATION

What Dermol Wash Cutaneous Emulsion contains:

The active ingredients in this product are isopropyl myristate (2.5% w/w), liquid paraffin (2.5% w/w), benzalkonium chloride (0.1% w/w) and chlorhexidine dihydrochloride

(0.1% w/w). The other ingredients are cetostearyl alcohol, macrogol cetostearyl ether (cetomacrogol 1000), phenoxyethanol and purified water.

What Dermol Wash looks like and contents of the pack

• The product is a white, non-greasy emulsion (lotion) that contains no dye or fragrance.

• The product is available in a plastic bottle with a pump dispenser containing 200 ml of lotion. (50 ml packs are also available to medical and allied professions.)

The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK.

The Manufacturer is Aeropak, Viking Road, Great Yarmouth, NR31 0NU, UK.

This leaflet was last revised in April 2016.

7.    GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS

•    Try to avoid using normal soaps or shower products (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.

•    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.

•    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.

•    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: Dermol Wash Cutaneous Emulsion, 00173/0407.

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