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PICKLES OINTMENT

Active substance(s): SALICYLIC ACID / SALICYLIC ACID / SALICYLIC ACID

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Pickles Ointment

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
50 % Salicylic Acid

3

PHARMACEUTICAL FORM
Keratolytic ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
To treat Corns and Hard Skin.

4.2

Posology and method of administration
Hard Skin: Apply a little ointment to Hard Skin for 4 nights, bathe, and allow
treated skin to cast itself Wash hands after use.
Corns: Fix a corn ring over the corn and apply a little ointment through the
hole directly onto it. Leave in place for 3 days then bathe the area. Replace
the treatment if corns persist.

4.3

Contraindications
Hypersensitivity to topical salicylate or any of the ingredients in Pickles
Ointment.
Not to be used by patients with diabetes or those with severe circulatory
disorders or peripheral neuropathy except following a doctor s permission or
recommendation.
Do not use if the callous/corn is infected or surrounding skin is inflamed or
broken.
Do not use on broken skin, moles, birthmarks, hairy warts or any other skin
lesions for which Pickles Ointment is not indicated.

4.4

Special warnings and precautions for use
Avoid contact with eyes or mucous membranes. If contact occurs flush with
water for 15 minutes. Avoid contact with normal skin around the callous/corn.
Avoid using on areas of broken or damaged skin. Discontinue treatment if
excessive irritation occurs.
Remove immediately any surplus ointment from normal skin tissue
Excessive prolonged use of topical salicylic acid may result in symptoms of
salicylism and therefore topical salicylic acid should not be used for prolonged
periods, in high concentrations, on large areas of the body.

4.5

Interaction with other medicinal products and other forms of interaction
There are no known interactions when used as indicated. However, salicylic
acid may increase the absorption of other topically applied medicines.
Concomitant use of Pickles Ointment and other topical medicines should
therefore be avoided.

4.6

Pregnancy and lactation
Whilst there are no known contra-indications to the use of Pickles Ointment
during pregnancy and lactation, the safety has not been established. Pickles
Ointment should therefore be used with caution or following professional
advice.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
A localised irritant reaction may occur if Pickles Ointment is applied to
normal skin surrounding the callous/corn. This may be controlled by
temporarily discontinuing the use of Pickles Ointment and by being careful to
apply it only to the callous/corn when treatment is resumed.

4.9

Overdose
Symptoms of acute systemic salicylate poisoning have been reported after
application of salicylic acid to large areas of skin and for prolonged periods.
Symptoms include dizziness, tinnitus, deafness, sweating, nausea and
vomiting, headache and confusion. In children drowsiness and metabolic
acidosis commonly occur, hypoglycaemia may be severe.
Salicylism may also occur in the unlikely event of large quantities being
ingested. Salicylism is unlikely to occur if Pickles Ointment is used as
indicated.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Salicylic acid is a bacteriostatic and fungicide. Used externally it has
keratolytic properties and produces slow and painless destruction of hard skin
and corns (also healthy skin).

5.2

Pharmacokinetic properties
Salicylic acid may be percutaneously absorbed. However, there is no evidence
of any systemic absorption from the use of Pickles Ointment.

5.3

Preclinical safety data
No other information relevant to the prescriber other than that already stated in
other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
50 % yellow petroleum jelly.

6.2

Incompatibilities
None stated.

6.3

Shelf life
60 months.

6.4

Special precautions for storage
Do not store above 25 C. Do not refridgerate or freeze.

6.5

Nature and contents of container
Slip lid tins of printed tin-plate containing 12 and 28g.

6.6

Special precautions for disposal
As in administration it is important to realise that the product does not
discriminate between Hard skin and Corns and Healthy Skin Ointment

must be removed from Good Skin and hands, immediately after applying the
product.

7

MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd
Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 40575/0006

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28 September 2004

10

DATE OF REVISION OF THE TEXT
11/08/2012

Expand Transcript

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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