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SALICYLIC ACID COLLODION B.P. METHYLATED

Active substance(s): SALICYLIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Salicylic Acid Collodion B.P. Methylated

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Salicylic Acid 12.0% w/v
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Topical solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the topical treatment of warts, corns or calluses.

4.2

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.

4.3

Contraindications
Hypersensitivity to salicylic acid or to any of the excipients listed in section
6.1.
Contraindicated in diabetics or individuals with impaired peripheral blood
circulation.
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.

4.4

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
inflammation resolves.
Highly flammable. Keep away from naked flames.
Do not use excessively.

4.5

Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.

4.6

Fertility, pregnancy and lactation
Topical application of large quantities of salicylic acid is not recommended
during pregnancy or lactation.

4.7

Effects on ability to drive and use machines
No significant effects have been reported.

4.8

Undesirable effects
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.

4.9

Overdose
Symptoms
Symptoms from topical administration of large quantities of salicylic acid
include thirst, tinnitus, headache, lethargy, confusion, vomiting, depression
and disorientation.
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
coma.
Emergency procedures
Aspiration and gastric lavage with supportive therapy such as replacement of
fluids and electrolytes.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Salicylic acid is keratolytic producing desquamation by solubilising the
intercellular cement in the stratum corneum.

5.2

Pharmacokinetic properties
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.

5.3

Preclinical safety data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Pyroxylin
Colophony
Castor oil
Industrial methylated spirit
Solvent ether

6.2

Incompatibilities
Salicylic acid is incompatible with iron salts and with oxidising substances.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Store in well closed containers in a cool place remote from fire.

6.5

Nature and contents of container
Dispensing packs
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.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Wise Pharmaceuticals Limited
Hani Wells Business Park
Unit 7
Hardicker Street
Manchester
M19 2RB
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 18374/0016

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
9th March 2005

10

DATE OF REVISION OF THE TEXT
03/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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