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Surgical Spirit Bp

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Surgical Spirit BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Methyl Salicylate 0.5% v/v Diethyl Phthalate 2.0% v/v

3.    PHARMACEUTICAL FORM

Spirit

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

For external use as a skin cleanser.

4.2    Posology and Method of Administration

Can be used by adults, children and the elderly.

4.3    Contra-Indications

Do not use where there is known sensitivity to the product.

4.4    Special Warnings and Special Precautions for Use

For external use only.

Highly flammable - no smoking.

Keep container tightly closed.

Keep away from sources of ignition.

Keep out of the reach of children.

4.5    Interactions with other Medicinal Products and other Forms of Interaction

None known.

4.6    Pregnancy and Lactation

Can be used during pregnancy and lactation.

4.7    Effects on Ability to Drive and Use Machines

Does not affect the ability to drive and use machines.

4.8    Undesirable Effects

None known.

4.9 Overdose

If accidentally ingested seek medical advice.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic Properties

The ingredients have antiseptic and cleansing properties.

5.2    Pharmacokinetic Properties

Topically absorbed into the epidermis.

Pre-clinical Safety Data

5.3


None stated

6.    PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

Castor oil    2.5% v/v

Industrial methylated spirit to 100% v/v

6.2    Incompatibilities

None known.

6.3    Shelf-Life

36 months.

6.4    Special Precautions for Storage

Store in a cool dry warehouse in an inflammable liquids storage area.

6.5    Nature and Content of Container

Amber plastic bottles with plastic cap containing 500ml, 2000ml and 5000ml.

6.6    Instruction for Use/Handling

N/A

7    MARKETING AUTHORISATION HOLDER

J M Loveridge plc Southbrook Road Southampton SO15 1BH

8.    MARKETING AUTHORISATION NUMBER(S)

PL 00531/5127R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 April 1988, Renewed 19 April 1993./ 11/05/1998.

10. DATE OF (PARTIAL) REVISION OF THE TEXT

January 1998