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SURGICAL SPIRIT BP

Active substance(s): DIETHYL PHTHALATE / METHYL SALICYLATE / VIRGIN CASTOR OIL

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Transcript
PARTICULARS TO APPEAR ON LABEL
BASE LABEL

1.

NAME OF THE MEDICINAL PRODUCT

Surgical Spirit BP
Methyl Salicylate
2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Contains: Methyl Salicylate
3.

LIST OF EXCIPIENTS

Other ingredients: Castor Oil, Diethyl Phthalate and Industrial Methylated Spirit
4.

PHARMACEUTICAL FORM AND CONTENTS

Bottle:
200 ml
5.

METHOD AND ROUTE(S) OF ADMINISTRATION

AGE
ADULTS, ELDERLY & CHILDREN

6.

HOW TO USE
DOSAGE
Apply to the skin using cotton wool.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE SIGHT AND REACH OF CHILDREN

Keep out of the reach and sight of children.
7.

OTHER SPECIAL WARNING(S), IF NECESSARY

For external use only.
8.

EXPIRY DATE

EXP
9.

SPECIAL STORAGE CONDITIONS

Not applicable
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Not applicable

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11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Activase Pharmaceuticals Limited
Boumpoulinas 11, 3rd Floor,
1060 Nicosia,
Cyprus
12.

MARKETING AUTHORISATION NUMBER(S)

PL 28444/0136
13.

BATCH NUMBER

BN
14.

GENERAL CLASSIFICATION FOR SUPPLY

Not applicable
15.

INSTRUCTIONS ON USE

Spirit for disinfecting and thorough cleansing of the skin.
Do not use this product after its ‘EXP’ date.
Please read the Package Leaflet on the reverse of this label before use.
16.

INFORMATION IN BRAILLE

Surgical Spirit BP

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SURGICAL SPIRIT BP
(Methyl Salicylate BP 0.5% v/v)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Surgical Spirit carefully to
get the best results from it.
-

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Surgical Spirit is and what it is used for
Before you use Surgical Spirit
How to use Surgical Spirit
Possible side effects
How to store Surgical Spirit
Further information
WHAT SURGICAL SPIRIT IS AND WHAT IT IS USED FOR
The name of your product is Surgical Spirit BP. It contains the active ingredient called Methyl
Salicylate. Surgical Spirit acts to tighten, harden and disinfect the outer layer of the skin. It is also
used for general sick-room purposes.

2.

BEFORE YOU USE SURGICAL SPIRIT
Do not use Surgical Spirit solution if you are allergic (hypersensitive) to Methyl Salicylate or any of
the other ingredients.
Do not apply to:
• mucous membranes (such as the linings of the mouth and nose) or scratched or damaged skin
• broken skin
Caution: Flammable. Keep away from naked flames. Harmful by inhalation.
Take special care with Surgical Spirit solution. This product is for external use only.
Pregnancy and Breast-feeding
Surgical Spirit can be used during pregnancy and lactation. It is advisable to consult your doctor or
pharmacist before using this product.
Important information about some of the ingredients of Surgical Spirit: This product contains
castor oil. May cause skin reactions.

3.

HOW TO USE SURGICAL SPIRIT
Follow the directions on this package leaflet or pack carefully, and ask your pharmacist to explain
any part you do not understand.
3

For adults, elderly and children: Apply to the skin using cotton wool.
If you accidentally swallow Surgical Spirit, please consult your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS
Like all medicines, Surgical Spirit may cause side-effects, although not everybody gets them.
Serious side effects –If any of the following happens, stop using Surgical Spirit solution and tell
your doctor immediately or go to the nearest hospital emergency department:


This product contains ethanol. Frequent use may produce irritation and dry skin.

If you notice any side-effects, consult your doctor or pharmacist.
5.

HOW TO STORE SURGICAL SPIRIT
Keep out of the reach and sight of children.
Keep the bottle tightly closed.
Do not use Surgical Spirit after expiry date which is stated on the label. The expiry date refers to the
last date of that month. Keep way from sources of ignition.
Surgical Spirit should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of this product no longer required. These measures will help to protect the
environment.

6.

FURTHER INFORMATION
What Surgical Spirit contains:
The active substance is Methyl Salicylate. The other ingredients are Castor Oil, Diethyl Phthalate,
Industrial Methylated Spirit. Castor Oil prevents the skin from drying and cracking.
What Surgical Spirit looks like and contents of the pack:
Surgical spirit is a solution and comes in glass bottle with plastic caps: 100ml, 200ml, 250ml, 500ml,
and 2000ml. It is also available in plastic container with plastic cap: 2000ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited, 11 Boumpoulinas, 3rd Floor, P.C. 1060, Nicosia, Cyprus.
Manufacturer
GlobeGen Laboratories Ltd., 1406 Coventry Road, South Yardley, Birmingham, B25 8AE, UK.
Date of last revision
September 2013

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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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