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SALICYLIC ACID COLLODION B.P. METHYLATED
Active substance(s): SALICYLIC ACID / SALICYLIC ACID / SALICYLIC ACID
NAME OF THE MEDICINAL PRODUCT
Salicylic Acid Collodion B.P. Methylated
QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid 12.0% w/v
For excipients, see 6.1.
For the topical treatment of warts, corns or calluses.
Posology and method of administration
For topical application
Adults including the elderly
Apply daily to the affected areas only and allow to dry.
Children under 12 years
Children over 2 years are to be treated under medical supervision, but
treatment of infants is not recommended.
Route of administration
For application to the affected areas on the surface of the skin.
Hypersensitivity to salicylic acid or to any of the excipients listed in section
Contraindicated in diabetics or individuals with impaired peripheral blood
Contraindicated for use on facial or anogenital warts or on large areas.
Not to be used on moles, birth marks, hairy warts or any other skin lesion for
which it is not indicated.
Not to be used on skin that is inflamed or broken.
Special warnings and precautions for use
For external use only.
Keep away from the eyes, mucous membranes and from cuts and grazes.
Avoid inhaling vapour.
Avoid spreading onto surrounding uninvolved healthy skin. If the treated area
becomes inflamed or painful, treatment should be suspended until the
Highly flammable. Keep away from naked flames.
Do not use excessively.
Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.
Fertility, pregnancy and lactation
Topical application of large quantities of salicylic acid is not recommended
during pregnancy or lactation.
Effects on ability to drive and use machines
No significant effects have been reported.
Salicylic acid may cause local skin irritation or inflammation and contact allergic
dermatitis has been reported.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Symptoms from topical administration of large quantities of salicylic acid
include thirst, tinnitus, headache, lethargy, confusion, vomiting, depression
Symptoms of accidental oral ingestion of salicylic acid include headache,
nausea, vomiting, diarrhoea and respiratory depression. Severe intoxication
may result in irritability, restlessness, incoherent speech, excitement,
hallucinations, delusions, delirium, mania, metabolic acidosis, stupor and
Aspiration and gastric lavage with supportive therapy such as replacement of
fluids and electrolytes.
Salicylic acid is keratolytic producing desquamation by solubilising the
intercellular cement in the stratum corneum.
Salicylic acid is absorbed percutaneously with maximal plasma levels after 6 12 hours; 65-85% of the dose is absorbed.
Following percutaneous absorption, salicylic acid is distributed in the
extracellular space and 58% is protein bound to albumin. Salicylates cross the
placenta and appear in breast milk.
Salicylates are metabolised in the liver by microsomal enzymes and either
conjugated with UDP-glucuronic acid to form phenyl or acyl glucuronides or
hydroxylated into gentisic acid. In the liver and kidneys, the carboxyl groups
are conjugated in the mitochondria to form salicylates or gentisurates.
65- 85% of topically administered salicylates are recoverable in the urine, 52%
of which are in the form of salicyluric acid, 42% as phenolic glucuronides of
salicylic acid and the rest as salicylic acid. Of a single dose, 95% is excreted
within 24 hours of its entry into the extracellular space.
Preclinical safety data
No relevant data.
List of excipients
Industrial methylated spirit
Salicylic acid is incompatible with iron salts and with oxidising substances.
Special precautions for storage
Store in well closed containers in a cool place remote from fire.
Nature and contents of container
500 ml amber glass bottle with white plastic screw cap with an aluminium
faced EPE liner.
100 ml amber glass bottle with a black low density polyethylene screw cap
with a polypropylene cone-shaped liner.
Patient packs or OTC packs as appropriate
5 and 10 ml amber glass bottles with a polypropylene, unwadded cap, having a
small spatula attached to the cap.
Not all pack sizes may be marketed.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
9th March 2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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