Compound V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Compound V.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic acid 17.0%w/w.
3 PHARMACEUTICAL FORM
Viscous, faintly yellow liquid for topical administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of verruca (plantar warts).
4.2 Posology and method of administration
All sufferers:
Apply to verruca one drop at a time with dropper-rod until verruca is covered. Allow to dry completely.
Avoid surrounding skin.
Repeat application daily with regular washing, for up to twelve weeks.
If condition persists, consult your doctor.
4.3 Contraindications
Do not use Compound V on moles, birth marks, hairy, genital or facial warts.
4.4 Special warnings and precautions for use
Do not apply to healthy skin or skin which is inflamed or broken.
If the verruca does not dissolve or gets worse, consult your doctor. If in doubt or have diabetes ask your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
No contraindications known.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
4.9 Overdose
None probable.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Salicylic acid facilitates desquamation by solubilising the intercellular cement that binds scales in the stratum corneum, thereby loosening the keratin.
5.2 Pharmacokinetic properties
Salicylic acid can be absorbed through the skin. It is excreted as salicyluric acid, phenolic glucuronides and as unchanged salicylic acid.
5.3 Preclinical safety data
The active ingredient in Compound V has a well documented safety record.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Acetone
Industrial methylated spirits 99% Pyroxylin (nitrocellulose DHM 10/25) Castor oil.
6.2 Incompatibilities
None known.
6.3 Shelf life
48 months unopened.
6.4 Special precautions for storage
No special precautions required
6.5 Nature and contents of container
Glass bottle with screw threaded plastic cap and plastic rod wad. Pack size 6.5ml.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Limited,
North Way,
Walworth Industrial Estate,
Andover,
SP10 5AZ United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0115
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/03/1999.
10 DATE OF REVISION OF THE TEXT
05/02/2008