Surgical Spirit Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Surgical Spirit BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl salicylate BP 0.5% v/v.
3 PHARMACEUTICAL FORM
Topical solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Used as an antiseptic for cleaning the skin and for general sickroom purposes. Intended for topical administration to human beings and as a general disinfectant.
4.2 Posology and method of administration
For children and adults, including the elderly.
Apply to the skin using cotton wool.
4.3 Contraindications
Hypersensitivity to the actives and any of the excipients On mucous membranes and excoriated skin surface.
4.4 Special warnings and precautions for use
For external use only. Caution: flammable. Keep away from naked flames.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, Pregnancy and lactation
Acceptable for use during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
None stated.
4.9 Overdose
Overdose from methyl salicylate occurs when someone accidentally or intentionally use the product orally. This may result in the development of nausea, vomiting, agitation, difficulty in breathing, dizziness and ringing in the ears, fever, acid-base disturbance etc. Also, it can cause severe, rapid-onset salicylate poisoning because of its liquid concentrated form and lipid solubility.
The management includes supportive measures, activated charcoal, IV fluids, and sodium bicarbonate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
This product acts as an astringent.
5.2 Pharmacokinetic properties
The product contracts the skin and thus stops seepage of fluid. The alcohol is lostmainly by evaporation, the other ingredients are absorbed by the skin and excreted in the urine.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Castor oil Diethyl phthalate Industrial methylated spirit
6.2 Incompatibilities
None stated.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Keep away from naked flame.
6.5 Nature and contents of container
Amber glass bottle with plastic caps: l00ml, 200ml, 250ml, 500ml, 2000ml. Plastic container with plastic cap: 2000ml
6.6 Special precautions for disposal
For external use only.
Flammable.
Keep away from naked flames.
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0136
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30th March 1984 / 29th June 1999
10 DATE OF REVISION OF THE TEXT
10/10/2013