Surgical Spirit BP

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METHYL SALICYLATE

Available from:

LCM Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATC code:

D11AX

INN (International Name):

METHYL SALICYLATE 0.5 % (V/V)

Pharmaceutical form:

CUTANEOUS SOLUTION

Composition:

METHYL SALICYLATE 0.5 % (V/V)

Prescription type:

OTC

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-10-31

Patient Information leaflet

Braille Warning! MPS cannot accept responsibility for any
errors in this proof after approval by the customer.
Whilst extreme care is taken in the setting of Braille, the
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the Braille text and specification.
MHRA HEADER BOX
PRODUCT TITLE
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
COLOURS USED
FONTS USED
Landscape peelable label
200ml
21633812
65 x 170mm
Surgical Spirit
Helvetica
Helvetica Neue
OCRB
Optima BQ
Process Yellow
Process Black
Process Magenta
Process Cyan
Keyline (Does not print)
Text free area (Does not print)
Braille
PCP HEADER BOX
OPERATOR
ARTWORK NO.
CRN
REASON FOR
CHANGE
SUFFIX
MHRA/IMB
SUBMISSION
REQUIRED
APPROVED BY
DATE
ISSUED BY
DATE
Yes
A
gill.kennedy/charlotte.strelzyn
669411
13137 & 13090
Deletion of 500ml pack size &
Downgrading of virgin castor oil
from an active to an excipient
21633813
Datamatrix:
VERIFIED
2
04.07.2016
FOR EXTERNAL USE ONLY
SURGICAL
SPIRIT
METHYL SALICYLATE
PREVENTS BED SORES & HARDENS SKIN
200ML
PEEL
HERE
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX FOR
FUTURE USE.
Used to prevent bed sores and harden the
skin of the feet.
APPLY THE SOLUTION TO THE SKIN.
• Do not use on broken skin.
• CAUTION: this medicine is flammable, keep
away from naked flames.
ADULTS, THE ELDERLY AND CHILDREN:
• Apply to the affected area using cotton wool
as required.
IF YOU ACCIDENTALLY SWALLOW SOME
go to hospital immediately, even if you feel
well. Take this container with you to show
which medicine you have swallowed.
PEEL WHERE SHOWN FOR
FURTHER PRECAUTIONS.
ACTIVE INGREDIENT:
methyl salicylate
0.5% v/v.
ALSO CONTAINS: industrial methylated
spirit 95% v/v, diethyl phthalate and
virgin castor oil.
Do

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Surgical spirit BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl Salicylate 0.5% v/v
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cutaneous Solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To prevent bed sores and for hardening the skin of the feet.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Topical application.
Apply directly to the skin with cotton wool._ _
Recommended Dose and Dosage Schedule
The product is suitable for use by adults, children and the elderly.
To be used as
required.
4.3
CONTRAINDICATIONS
Hypersensitivity to methyl salicylate,or any of the excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not apply to broken skin.
Labels state:
FOR EXTERNAL USE ONLY.
Keep out of the sight and reach of children.
Do not use on broken skin.
Caution: this preparation is flammable, keep away from naked flames.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
There have been reports that topical salicylates may potentiate the
anticoagulant
effects of warfarin.
4.6
FERTILITY, PREGNANCY AND LACTATION
No evidence is available as to the safety of the product when used
during pregnancy
and lactation. In such cases therefore use with caution.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8
UNDESIRABLE EFFECTS
None known.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions
via the national reporting system, ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal.
4.9
OVERDOSE
This product is recommended for external use only and as such overdose
is unlikely.
Absorption of methyl alcohol through the skin, ingestion or inhalation
of the vapour_ _
may produce systemic effects. Methyl salicylate may be absorbed
throu