Surgical Spirit Bp
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