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IMPETUS CREAM

Active substance(s): BENZALKONIUM CHLORIDE / CHLORHEXIDINE DIHYDROCHLORIDE / ISOPROPYL MYRISTATE / LIQUID PARAFFIN

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Transcript
Annotated Version – Not For Marketing
PA C K A G E L E A F L E T
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
Please read all of this leaflet carefully before you start using this medicine.
associated with products
Keep this leaflet. You may need to read it again.
containing chlorhexidine. You
Ask your doctor or pharmacist if you need more information or advice.must not use Impetus Cream if
you have had problems with
In this leaflet:
chlorhexidine-containing
1. What Impetus Cream is and what it is used for
products in the past.
2. Before you use Impetus Cream
3. How to use Impetus Cream
4. Possible side effects
5. How to store Impetus Cream
6. Further information
7. General advice on looking after dry skin conditions
Information for the user

1. WHAT IMPETUS CREAM IS AND WHAT IT IS USED FOR
• Impetus Cream is an antimicrobial and emollient (softening and moisturising) treatment
for application to dry or problem skin.
• It is for use in two ways:
– as a leave-on application
– as a soap-substitute.
• It helps treat and prevent dry and itchy (pruritic) skin conditions, especially eczema
and dermatitis.
• All age groups can use Impetus Cream, including babies.
• There are two types of active ingredient in this product:
– Benzalkonium chloride and chlorhexidine dihydrochloride are antimicrobials.
These help to:
– combat bacteria present on your skin that can make eczema worse
– prevent infection caused by scratching itchy skin.
– Liquid paraffin and isopropyl myristate are emollients which help 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
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 IMPETUS CREAM
Do not use Impetus Cream if you are allergic (hypersensitive) to benzalkonium chloride,
chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other
ingredients of Impetus Cream listed in section 6.
Take special care when using this product:
• 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 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.
Important information about one of the ingredients of Impetus Cream
The product contains cetostearyl alcohol. This ingredient may cause local skin reactions
(eg contact dermatitis) in a small number of sensitive people. If you have been told by your
doctor that you are sensitive to cetostearyl alcohol, please talk to your doctor before using
this product.

3. HOW TO USE IMPETUS CREAM

JP105T-3

Use it only on the skin. For maximum benefit you should use it on a regular basis and
as often as required. Before using the 500 g bottle, turn the top of the pump dispenser
anti-clockwise to unlock it.
The same instructions apply for all age groups:For use as a leave-on application:
• Apply Impetus Cream to the affected areas.
• Gently smooth into the skin.
• If necessary, allow time for any excess to soak in. Do not rub the skin vigorously.
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
continued…
to cetostearyl alcohol in particular.

• Reapply as often as required.
• If you are applying another treatment to the same areas of skin as Impetus Cream,
try to 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
If you experience any of the
or shower
gel. stop using
• Use Impetus Cream to wash with instead of your ordinary soap
following
reactions
It will not foam or lather like ordinary cosmetic products.
Impetus Cream and get urgent
towel help:
(avoidswelling
rubbingof the face,
• After washing, bathing or showering, pat the skin dry with a soft
medical
as this can make dry skin conditions worse).
lips, tongue or throat; a sudden
If you forget to use Impetus Cream
uncharacteristic red itchy skin rash
Do not worry if you occasionally forget to use it, just carry on using
the product
as described
(hives)
away from
the site of
the next time you require it.
application; wheezing or breathing
If the product gets into the eyes
difficulty: feeling faint or dizzy; a
The product may cause irritation if it gets into the eyes. Rinse thestrange
eyes with
plentytaste
of water.
metallic
in the
If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists,
mouth; or collapse. You may be
seek medical advice.
having a serious allergic reaction.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Impetus Cream can cause side effects, although not everybody gets them.
This product has been specially designed for use on dry or problem skin areas anywhere
on the body, but in some very rare cases it can cause local skin reactions (involving redness,
irritation and/or itching). Reactions may occasionally occur if used excessively as a leave-on
application in areas of folded skin such as the groin area.
Stop using this cream 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 Impetus Cream
If you accidentally swallow the product and you then feel unwell, seek medical attention.
Do not attempt to cause vomiting.
Rarely, Impetus Cream can cause skin reactions

on treated areas (involving redness, irritation and/
or itching).
Keep
out
of
reach
and
sight
of
children.

• Do not use Impetus Cream 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 30°C.
• Always replace the cap after use.
• In the case of the 500 g bottle, it is advisable to turn the top of the pump dispenser
clockwise to lock it.
macrogol cetostearyl ether
(cetomacrogol 1000). (Ref.
6. FURTHER INFORMATION
PL00173/0399-0005)
What Impetus Cream contains:
The active ingredients in this product are benzalkonium chloride (0.1% w/w), chlorhexidine
dihydrochloride (0.1% w/w), liquid paraffin (10% w/w) and isopropyl myristate (10% w/w).
The other ingredients are cetostearyl alcohol, glycerol, cetomacrogol 1000, phenoxyethanol,
disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and purified
water.
What Impetus Cream looks like and contents of the pack
• The product is a white, non-greasy cream that contains no dye or fragrance.
• The product is available in a plastic bottle containing 500 g or in a plastic tube containing
100g. (30 g 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.
September 2014
This leaflet was last approved in April 2010.

5. HOW TO STORE IMPETUS CREAM

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.
Reporting
of warm,
side effects
try to use
not hot, water and avoid staying in the bath for long
• When bathing,
If could
you get
any side
effects,
talk to your
doctor, pharmacist or nurse. This includes any
periods. This
make
dry skin
conditions
worse.
possible
side
effects
not
listed
in
this
leaflet.
You
can labelled
also report
side effects directly
Try
to
avoid
using
normal
soaps
or
shower
products
(even
those
“moisturising”).

via the
Yellow
at: www.mhra.gov.uk/yellowcard.
This is because
they
tend Card
to dryScheme
and irritate
the skin. Avoid using products containing
reporting
provideYou
more
information
on the
safety of this
fragrances, By
as these
canside
alsoeffects
cause you
skincan
problems.
should
try to use
a fragrance-free
emollient “soap
substitute” instead. This type of product will not foam or lather but will
medicine.
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.
• 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.

JP105T-3

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: Impetus Cream, 00173/0399.
This is a service provided by the Royal National Institute of Blind People (RNIB).

PA C K A G E L E A F L E T
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 Impetus Cream is and what it is used for
2. Before you use Impetus Cream
3. How to use Impetus Cream
4. Possible side effects
5. How to store Impetus Cream
6. Further information
7. General advice on looking after dry skin conditions

1. WHAT IMPETUS CREAM IS AND WHAT IT IS USED FOR

Specialtreatment
warnings and
• Impetus Cream is an antimicrobial and emollient (softening and moisturising)
for application to dry or problem skin.
precautions
• It is for use in two ways:
As with any product,
– as a leave-on application
severe generalised
– as a soap-substitute.
allergic reactions (see
eczema
• It helps treat and prevent dry and itchy (pruritic) skin conditions, especially
Section
4) are possible.
and dermatitis.
Very
rare
reports of such
• All age groups can use Impetus Cream, including babies.
reactions
in
susceptible
There
are
two
types
of
active
ingredient
in
this
product:

individuals, leading to a
– Benzalkonium chloride and chlorhexidine dihydrochloride are antimicrobials.
These help to:
drop in blood pressure
– combat bacteria present on your skin that can make eczema worse
and even to
– prevent infection caused by scratching itchy skin.
unconsciousness, have
– Liquid paraffin and isopropyl myristate are emollients which help to:been associated with
– soften, moisturise and protect your skin by trapping moisture in the
skin containing
products
and restoring the normal protective function of the skin
chlorhexidine. You must
– prevent the skin-drying and irritant effects that can be caused by washing and
use Impetus Cream if
bathing and by the soaps, foaming additives and fragrances usednot
in ordinary
you have had problems
skin cleansing products.
with chlorhexidineyour doctor
• This product can be used in addition to any other emollients or treatments
or pharmacist may have given or prescribed for you to treat your dry skin
condition.
containing
products in
2. BEFORE YOU USE IMPETUS CREAM

the past.

Do not use Impetus Cream if you are allergic (hypersensitive) to benzalkonium chloride,
chlorhexidine dihydrochloride, liquid paraffin, isopropyl myristate, or any of the other
ingredients of Impetus Cream listed in section 6.
Take special care when using this product:
• 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 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.
Important information about one of the ingredients of Impetus Cream
The product contains cetostearyl alcohol. This ingredient may cause local skin reactions
(eg contact dermatitis) in a small number of sensitive people. If you have been told by your
doctor that you are sensitive to cetostearyl alcohol, please talk to your doctor before using
this product.

3. HOW TO USE IMPETUS CREAM

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
continued…
cetostearyl alcohol in particular.

JP104T-3

Use it only on the skin. For maximum benefit you should use it on a regular basis and
as often as required. Before using the 500 g bottle, turn the top of the pump dispenser
anti-clockwise to unlock it.
The same instructions apply for all age groups:For use as a leave-on application:
• Apply Impetus Cream to the affected areas.
• Gently smooth into the skin.
If necessary,
allow
time for anylocal
excess
to reactions
soak in. Do(e.g.
not rub
the skin
vigorously.
If you•have
previously
experienced
skin
contact
dermatitis)
to any of the

• Reapply as often as required.
• If you are applying another treatment to the same areas of skin as Impetus Cream,
try to avoid mixing the two products. This can be achieved by applying the treatments
soak in.
alternately, leaving sufficient time to allow the previous application
If youtoexperience
any of the
For use as a soap substitute
following reactions stop using
or shower
gel. and get urgent
Impetus
Cream
• Use Impetus Cream to wash with instead of your ordinary soap
It will not foam or lather like ordinary cosmetic products.
medical help: swelling of the
rubbing
• After washing, bathing or showering, pat the skin dry with a soft
face,towel
lips,(avoid
tongue
or throat; a
as this can make dry skin conditions worse).
sudden uncharacteristic red itchy
If you forget to use Impetus Cream
skinthe
rash
(hives)
from the
Do not worry if you occasionally forget to use it, just carry on using
product
as away
described
site
of
application;
wheezing
or
the next time you require it.
breathing
difficulty:
feeling
faint
If the product gets into the eyes
oreyes
dizzy;
a strange
The product may cause irritation if it gets into the eyes. Rinse the
with
plenty of metallic
water. taste
If rinsing one eye, take care to avoid washing product into the other
eye.
If irritation
persists, You
in the
mouth;
or collapse.
seek medical advice.
may be having a serious allergic

4. POSSIBLE SIDE EFFECTS

reaction.

Like all medicines, Impetus Cream can cause side effects, although not everybody gets them.
This product has been specially designed for use on dry or problem skin areas anywhere on
the body, but in some very rare cases it can cause local skin reactions (involving redness,
irritation and/or itching). Reactions may occasionally occur if used excessively as a leave-on
application in areas of folded skin such as the groin area.
Stop using this cream 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 Impetus Cream
If you accidentally swallow the product and you then feel unwell, seek medical attention.
Do not attempt to cause vomiting.

Rarely, Impetus Cream
can cause skin reactions
• Keep out of reach and sight of children.
on treated areas
and carton.
(involving
redness,
• Do not use Impetus Cream after the expiry date shown on the container
The expiry date refers to the last day of that month.
irritation and/or itching).
5. HOW TO STORE IMPETUS CREAM

• Do not store above 30°C.
• Always replace the cap after use.
• In the case of the 500 g bottle, it is advisable to turn the top of the pump dispenser
clockwise to lock it.
macrogol cetostearyl ether

6. FURTHER INFORMATION

(cetomacrogol 1000) - ref.

PL 00173/0399-0005
What Impetus Cream contains:
The active ingredients in this product are benzalkonium chloride (0.1% w/w), chlorhexidine
dihydrochloride (0.1% w/w), liquid paraffin (10% w/w) and isopropyl myristate (10% w/w).
The other ingredients are cetostearyl alcohol, glycerol, cetomacrogol 1000, phenoxyethanol,
disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and purified
water.
What Impetus Cream looks like and contents of the pack
• The product is a white, non-greasy cream that contains no dye or fragrance.
• The product is available in a plastic bottle containing 500 g or in a plastic tube containing
100g. (30 g 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 approved in April 2010. September 2014
Reporting of side
7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS.
effects
Emollients help soften, moisturise and protect the skin. They play a central role in the
If you• get
any side
treatment and management of dry skin conditions. For maximum effect, they should be
effects,applied
talk to regularly
your
and as often as needed.
doctor,
pharmacist
or
• When bathing, try to use warm, not hot, water and avoid staying in the bath for long
nurse. periods.
This includes
This could make dry skin conditions worse.
any possible
side
• Try to avoid using normal soaps or shower products (even those labelled “moisturising”).
is because
they tend to dry and irritate the skin. Avoid using products containing
effects This
not listed
in this
as these can also cause skin problems. You should try to use a fragrance-free
leaflet. fragrances,
You can also
emollient “soap substitute” instead. This type of product will not foam or lather but will be
report side
effects
better for your dry skin condition.
directly via the Yellow
Breaking the itch-scratch cycle.
Card•Scheme
at:skin conditions like eczema and dermatitis are itchy, and can be quite sore.
Some dry
www.mhra.gov.uk/
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
yellowcard.
even greater.
By reporting
side It is better if scratching can be avoided by reducing the itching. The regular
use of emollients or moisturisers can help with this.
effects you can provide
You may find it helpful to contact NHS Direct (tel: 0845 4647) or a patient support
more• information
on the
group such as the National Eczema Society (tel: 0800 0891122, 8am to 8pm Mon-Fri)
safety of
this
medicine.
for information about your skin condition.

JP104T-3

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: Impetus Cream, 00173/0399.
This is a service provided by the Royal National Institute of Blind People (RNIB).

Expand view ⇕

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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