FRIARS BALSAM BP

Active substance: SUMATRA BENZOIN GROUND

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Transcript
1. What the medicine is for

Important information about Friars’ Balsam
•  his medicine can be inhaled to relieve the
T
symptoms of colds.
•  can also be applied to the skin as a mild
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antiseptic dressing.
• t can be used by adults and children over
I
3 months.

FRONT FACE TOP

Do not….

• Take by mouth. See section 3.
•  se on children under 3 months as an
U
inhalant.
•  ighly flammable. Keep away from naked
H
flames.
Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.
•  eep this leaflet. You may need to read it
K
again.
•  sk your pharmacist if you need any more
A
information or advice.
• f any of the side effects gets serious, or if
I
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Friars’ Balsam contains benzoin which acts as a
decongestant for the relief of cold symptoms.
It also has antiseptic properties.

2.  efore you use this
B
medicine
 not use the medicine if you or
Do
your child have….

•  n allergy to any of the ingredients listed in
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section 6.
•  r for a child under 3 months as an inhalant.
O
Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might be
pregnant or are breastfeeding. Using Friars’
Balsam as directed is not likely to cause any ill
effects.

3. How to use this medicine
For colds by inhaling the vapour.
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dults, the elderly and children
over 3 months

•  dd one 5ml spoonful to 568ml (1 pint) of hot
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(not boiling) water and inhale the steamy vapour.
•  epeat after 4 hours if required.
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See section 6 for advice on containers to use.

Children under 3 months

Do not use for children under 3 months as an
inhalant unless your doctor tells you to.

Adults, the elderly and children

•  pply undiluted to the affected area twice a
A
day.
FOR EXTERNAL USE ONLY.

If you swallow some

If you accidentally swallow some see a doctor
straight away. Take the pack with you to show
which medicine you have swallowed.

4. Possible side effects

Like all medicines Friars’ Balsam can have side
effects, although these don’t affect everyone.
Possible side effects are:
•  llergic skin reactions, such as itching, rashes or
A
eczema may occur.
•  requent application to the skin may cause
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dryness and irritation.
If you notice these or any other side effects, stop
use and tell your doctor or pharmacist. They will
tell you what to do.
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.
Alternatively you can call Freephone 0808 100 3352
(available from 10am to 2pm Mondays to Fridays).
By reporting side effects you can help provide more
information on the safety of this medicine.

Turn over
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Data Matrix: 23708403 VERIFIED

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Colours Used

What is in this medicine

The active ingredients are: prepared storax
10% w/v, benzoin sumatra 10% w/v.
The other ingredients are: aloes, ethanol and
purified water.

What the medicine looks like

Process Black

6. Further information

Friars' Balsam

Leaflet

50ml

23708403

237084

210 x 148mm flat (27 x 148mm folded)

4

Product
Title

Component

Pack Size

PCP No.

RM No.

Dimensions

Proof No.

Friars’ Balsam is a dark brown liquid which smells
of alcohol.
It is supplied in 50ml bottles.

Which containers are best to use for
diluting Friars’ Balsam
MHRA Header Box

Dilute the balsam as described in section 3 (How
to use this medicine) using a small bowl of the
Friars' Balsam
Product
type normally found in most kitchens. The use
Title
of a stainless steel or glass bowl is recommended
whenever possible. Plastic containers are not
Component
Leaflet
suitable and may become irreversibly stained
Pack Size
50ml
by the product. Residues on steel or glass can
normally beNo.
PCP removed using neat detergent and
23708403
warm water, or methylated spirit.

Colours Used

Process Black
Keyline (Does not print)

237084

RM No.

Marketing authorisation holder and
210 x 148mm flat (27 x 148mm folded)
Dimensions
manufacturer
L.C.M. ProofHuddersfield, HD7 5QH, UK.
Ltd., No.
4
Date
This leaflet was revised in August 2013

01.08.2013

23708403

PCP Header Box
Printer

Chesapeake, Tewkesbury

RMS No.

1436

Operator

Approved by
Date

gill.kennedy

Artwork No 456131
Ref CRN 10504

CRN

10511

Reason for
Change

Amends to section 4.8 of SPC for
safety information
Issued by
Date

MHRA/IMB
submission Yes
required

MHRA Header Box

REVERSE FACE TOP

•  eep it out of the sight and reach of children.
K
•  o not store above 25°C.
D
•  o not use after the expiry date shown on the
D
carton. The expiry date refers to the last day of
that month.
•  edicine should not be disposed of via
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wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

Keyline (Does not print)

5. Storing this medicine

01.08.2013

(storax, benzoin)

As an antiseptic apply it to the skin.

Date

Friars’ Balsam

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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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