DERMOL 500 LOTION

Active substance: LIQUID PARAFFIN

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PAC K AGE LEAF LET
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 or pharmacist if you need more information or advice.
In this leaflet:
1. What Dermol 500 Lotion is and what it is used for
2. Before you use Dermol 500 Lotion
3. How to use Dermol 500 Lotion
4. Possible side effects
5. How to store Dermol 500 Lotion
6. Further information
7. General advice on looking after dry skin conditions

1. WHAT DERMOL 500 LOTION IS AND WHAT IT IS USED FOR
• 
Dermol 500 Lotion is an antimicrobial and emollient (softening and moisturising) treatment
for application to dry or problem skin.
•  is for use in two ways:
It
–  s a leave-on application
a
–  s a soap-substitute
a
•  helps treat and prevent dry and itchy (pruritic) skin conditions, especially eczema and
It
dermatitis.
• ll age groups can use Dermol 500 Lotion, including babies.
A
• 
There are two types of active ingredient in this product:
–  enzalkonium chloride and chlorhexidine dihydrochloride are antimicrobials. These
B
help to:
–  ombat bacteria present on your skin that can make eczema worse
c
– prevent infection caused by scratching itchy skin.
–  iquid paraffin and isopropyl myristate are emollients which help to:
L
–  often, moisturise and protect your skin by trapping moisture in the skin and restoring
s
the normal protective function of the skin
–  revent the skin-drying and irritant effects that can be caused by washing and bathing
p
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 DERMOL 500 LOTION

Do not use Dermol 500 Lotion if you are allergic (hypersensitive) to benzalkonium chloride,
chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other
ingredients of Dermol 500 Lotion 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 500 Lotion if you have had problems with chlorhexidine-containing
products in the past.
Take care when using this product:
•  or patients with very sensitive skin, it is generally a good idea to start any new treatment
F
on a small test area first, in case any side effect occurs (see Section 4 below). This is
especially important when treating the face or young children. Thereafter, treatments may
be applied more generously, as required.
• Avoid getting it in the eyes, especially when using it on the face.
• 
When used as a soap substitute in the bath or shower the product 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).
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 500 Lotion
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.
Use it only on the skin. For maximum benefit you should use this product on a regular basis
and as often as required.
Before using the 500 ml bottle, 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.
The same instructions apply for all age groups:For use as a leave-on application
• 
Apply Dermol 500 Lotion to the affected areas.
• 
Gently smooth into the skin.
• f necessary, allow time for any excess to soak in. Do not rub the skin vigorously.
I
•  eapply as often as required.
R

continued…
Dermol 500 Lotion PIL JP5_14_1.indd 1

JP5/14/1 201284

3. HOW TO USE DERMOL 500 LOTION

13/10/2014 11:47

•  you are applying another treatment to the same areas of skin as Dermol 500 Lotion, try to
If
avoid mixing the two products. This can be achieved by applying the treatments alternately,
leaving sufficient time to allow the previous application to soak in.
For use as a soap substitute
• 
Use Dermol 500 Lotion to wash with instead of your ordinary soap or shower gel. It will not
foam or lather like ordinary cosmetic products.
• 
After washing, bathing or showering, pat the skin dry with a soft towel (avoid rubbing as
this can make dry skin conditions worse).
If you forget to use Dermol 500 Lotion
Do not worry if you occasionally forget to use it, just carry on using the product as described
the next time you require it.
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 500 Lotion can cause side effects, although not everybody gets
them.
If you experience any of the following reactions stop using Dermol 500 Lotion 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 500 Lotion 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 lotion and tell your doctor or pharmacist:
•  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
If
mentioned in this leaflet.
If you swallow Dermol 500 Lotion
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 500 LOTION
• 
Keep out of reach and sight of children.
•  not use Dermol 500 Lotion after the expiry date shown on the container and carton,
Do
or after 18 months of first opening the container. The expiry date refers to the last day of
that month.
•  not store above 25°C.
Do
• 
After using the 500 ml bottle it is advisable to turn the top of the pump dispenser clockwise
to lock it.

6. FURTHER INFORMATION

What Dermol 500 Lotion contains:
The active ingredients in this product are benzalkonium chloride (0.1% w/w), chlorhexidine
dihydrochloride (0.1% w/w), liquid paraffin (2.5% w/w) and isopropyl myristate (2.5% w/w).
The other ingredients are cetostearyl alcohol, macrogol cetostearyl ether (cetomacrogol
1000), phenoxyethanol and purified water.
What Dermol 500 Lotion looks like and contents of the pack
• 
The product is a white, non-greasy lotion that contains no dye or fragrance.
• 
This bottle contains 500 ml of lotion. The bottle is fitted with a pump dispenser.
(50 ml packs are also available to the medical and allied professions.)
The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK.
The Manufacturer is Fleet Laboratories Ltd, 94 Rickmansworth Road, Watford, Herts,
WD18 7JJ, UK.
This leaflet was last revised in September 2014.

7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS

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 500 Lotion, 00173/0051.
This is a service provided by the Royal National Institute of Blind People (RNIB).

Dermol 500 Lotion PIL JP5_14_1.indd 2

JP5/14/1 201284

• 
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.
•  to avoid using normal soaps or shower products (even those labelled “moisturising”).
Try
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.
• reaking the itch-scratch cycle.
B
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.
• 
You may find it helpful to contact NHS Direct (tel: 0845 4647) or a patient support group
such as the National Eczema Society (tel: 0800 0891122, 8am to 8pm Mon-Fri) for
information about your skin condition.

13/10/2014 11:47

PAC K AGE L EAF LET
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 or pharmacist if you need more information or advice.
In this leaflet:
1. What Dermol 500 Lotion is and what it is used for
2. Before you use Dermol 500 Lotion
3. How to use Dermol 500 Lotion
4. Possible side effects
5. How to store Dermol 500 Lotion
6. Further information
7. General advice on looking after dry skin conditions

1. WHAT DERMOL 500 LOTION IS AND WHAT IT IS USED FOR
• 
Dermol 500 Lotion is an antimicrobial and emollient (softening and moisturising) treatment
for application to dry or problem skin.
• It is for use in two ways:
–  s a leave-on application
a
–  s a soap-substitute
a
•  helps treat and prevent dry and itchy (pruritic) skin conditions, especially eczema and
It
dermatitis.
• All age groups can use Dermol 500 Lotion, including babies.
• There are two types of active ingredient in this product:
–  enzalkonium chloride and chlorhexidine dihydrochloride are antimicrobials. These
B
help to:
– combat bacteria present on your skin that can make eczema worse
– prevent infection caused by scratching itchy skin.
–  iquid paraffin and isopropyl myristate are emollients which help to:
L
–  often, moisturise and protect your skin by trapping moisture in the skin and restoring
s
the normal protective function of the skin
–  revent the skin-drying and irritant effects that can be caused by washing and bathing
p
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 DERMOL 500 LOTION

Do not use Dermol 500 Lotion if you are allergic (hypersensitive) to benzalkonium chloride,
chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other
ingredients of Dermol 500 Lotion 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 500 Lotion if you have had problems with chlorhexidine-containing
products in the past.
Take care when using this product:
•  or patients with very sensitive skin, it is generally a good idea to start any new treatment
F
on a small test area first, in case any side effect occurs (see Section 4 below). This is
especially important when treating the face or young children. Thereafter, treatments may
be applied more generously, as required.
• Avoid getting it in the eyes, especially when using it on the face.
• 
When used as a soap substitute in the bath or shower the product 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).
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 500 Lotion
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.
Use it only on the skin. For maximum benefit you should use this product on a regular basis
and as often as required.
Before using the 500 ml bottle, 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.
The same instructions apply for all age groups:For use as a leave-on application
• 
Apply Dermol 500 Lotion to the affected areas.
• 
Gently smooth into the skin.
•  necessary, allow time for any excess to soak in. Do not rub the skin vigorously.
If
• 
Reapply as often as required.

continued…
Dermol 500 Lotion PIL JP47_14_1.indd 1

JP47/14/1   201283

3. HOW TO USE DERMOL 500 LOTION

13/10/2014 11:47

•  you are applying another treatment to the same areas of skin as Dermol 500 Lotion, try to
If
avoid mixing the two products. This can be achieved by applying the treatments alternately,
leaving sufficient time to allow the previous application to soak in.
For use as a soap substitute
• 
Use Dermol 500 Lotion to wash with instead of your ordinary soap or shower gel. It will not
foam or lather like ordinary cosmetic products.
• 
After washing, bathing or showering, pat the skin dry with a soft towel (avoid rubbing as
this can make dry skin conditions worse).
If you forget to use Dermol 500 Lotion
Do not worry if you occasionally forget to use it, just carry on using the product as described
the next time you require it.
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 500 Lotion can cause side effects, although not everybody gets
them.
If you experience any of the following reactions stop using Dermol 500 Lotion 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 500 Lotion 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 lotion and tell your doctor or pharmacist:
•  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
If
mentioned in this leaflet.
If you swallow Dermol 500 Lotion
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 500 LOTION
• 
Keep out of reach and sight of children.
•  not use Dermol 500 Lotion after the expiry date shown on the container and carton,
Do
or after 18 months of first opening the container. The expiry date refers to the last day of
that month.
•  not store above 25°C.
Do
• 
After using the 500 ml bottle it is advisable to turn the top of the pump dispenser clockwise
to lock it.

6. FURTHER INFORMATION

What Dermol 500 Lotion contains:
The active ingredients in this product are benzalkonium chloride (0.1% w/w), chlorhexidine
dihydrochloride (0.1% w/w), liquid paraffin (2.5% w/w) and isopropyl myristate (2.5% w/w).
The other ingredients are cetostearyl alcohol, macrogol cetostearyl ether (cetomacrogol
1000), phenoxyethanol and purified water.
What Dermol 500 Lotion looks like and contents of the pack
• 
The product is a white, non-greasy lotion that contains no dye or fragrance.
• 
This bottle contains 500 ml of lotion. The bottle is fitted with a pump dispenser.
(50 ml packs are also available to the 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 September 2014.

7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS

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 500 Lotion, 00173/0051.
This is a service provided by the Royal National Institute of Blind People (RNIB).

Dermol 500 Lotion PIL JP47_14_1.indd 2

JP47/14/1   201283

• 
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.
•  to avoid using normal soaps or shower products (even those labelled “moisturising”).
Try
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.
• reaking the itch-scratch cycle.
B
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.
• 
You may find it helpful to contact NHS Direct (tel: 0845 4647) or a patient support group
such as the National Eczema Society (tel: 0800 0891122, 8am to 8pm Mon-Fri) for
information about your skin condition.

13/10/2014 11:47

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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