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Salactol Collodion

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PACKAGE LEAFLET Information for the user

Salactdl

collodion,

salicylic acid, lactic acid

Please read all of this leaflet carefully before you start using this product.

Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice.

In this leaflet:

1.    What Salactol is and what it is used for

2.    Before you use Salactol

3.    How to use Salactol

4.    Possible side effects

5.    How to store Salactol

6.    Further information

1.    WHAT SALACTOL IS AND WHAT IT IS USED FOR

•    Salactol is a collodian wart paint for treating warts, verrucas, corns and calluses.

-    Warts and verrucas are small excessive growths of skin caused by a type of virus.

Warts often occur on the fingers, or on the back of the hands. You can recognise the common wart by the rough “cauliflower-like” appearance of the surface. Verrucas occur only on the sole of the foot. They can be painful, and often look like a small white ring of skin with a black dot in the centre. The virus is very infectious. This means that warts and verrucas can grow and spread, particularly if left untreated. The virus can also be transferred from one person to another.

-    Corns and calluses are hard, thick pads of skin caused by pressure and friction. They usually occur on the feet due to poorly fitting shoes. They can also occur on the hands.

•    Salactol is suitable for use by adults, children and the elderly.

•    The active ingredients in this product are salicylic acid and lactic acid.

•    The active ingredients work by:

-    softening the hard skin growth, making it easier to remove with a pumice stone or emery board;

-    helping to kill the virus that causes warts and verrucas.

2.    BEFORE YOU USE SALACTOL

Do not use Salactol if you are allergic (hypersensitive) to salicylic acid, lactic acid or any of the other ingredients of Salactol listed in Section 6.

•    Do not use this product anywhere on or near your face, armpits, breasts, bottom or genital (sex) area.

•    Do not use it on birthmarks, moles, warts with hairs growing from them, or any other spots.

•    Do not use this product if you are diabetic or suffer from poor blood circulation to your hands or feet.

Take special care when using this product:

•    If you are unsure whether you have a wart, verruca, corn or callus that is suitable for treatment with Salactol, ask your doctor or pharmacist before starting treatment.

• Apply Salactol carefully, to the wart, verruca, corn or callus only, by painting it on using the applicator attached to the inside of the cap:

-    take care not to apply the product to surrounding healthy skin, especially on young children’s delicate skin, because this may cause irritation;

-    do not apply excessive amounts.

•    Keep the product away from your eyes, nose, and mouth, and from broken skin, cuts and grazes.

•    Avoid spillage as this may cause damage to you, your clothing and your possessions (see Section 4).

•    This product is volatile and highly flammable. Do not use it near flames or ignition sources (e.g. burning cigarettes or anything else that might ignite it).

•    Avoid inhaling the vapour.

Using other medicines

This product is not known to affect, or to be affected by any other medicines.

Pregnancy and breast feeding

This product can be used during pregnancy and while breast feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

3.    HOW TO USE SALACTOL

Use it only on warts, verrucas, corns and calluses on sites for which it is recommended.

For adults, children and the elderly:

Follow these steps once every day, usually in the evening. Carry on using the product in this way until the wart, verruca, corn or callus disappears:

A.    Soak the affected area in warm water for 2 to 3 minutes.

B.    Dry the area thoroughly, using your own towel if you have a wart or verruca (this will help stop the infection spreading to other people).

C.    Gently rub away any loose, hard skin from the surface of the wart, verruca, corn or callus with an emery board or a piece of pumice stone:

-    if you are treating a wart or verruca, do not let anyone else use the emery board or pumice stone after you as the infection may spread to them.

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D.    Unscrew the cap of the bottle and, using the applicator attached to the inside of the cap, carefully apply a few drops of the paint to the top of the wart, verruca, corn or callus only:

-    avoid spreading onto surrounding healthy skin;

-    allow each drop to dry for a few minutes before applying the next drop.

continued...


E.    If the treated area is on the sole of the foot, cover it with an adhesive plaster to help prevent the virus from spreading.


Elsewhere, treated areas need not be covered.

F.    Always replace the cap of the bottle tightly after use.

G.    Repeat steps A to F every evening, after removing any plaster from the previous day.

H.    The length of treatment will vary depending on the size and resistance of the wart, verruca, corn or callus:

-    some may go in a relatively short time;

-    some warts and verrucas can require up to 12 weeks treatment before they disappear;

-    it is important that you do not give up on the treatment until the wart, verruca, corn or callus has disappeared (unless irritation occurs, see section 4 below);

-    if the wart, verruca, corn or callus has not disappeared after twelve weeks of treatment tell your doctor or pharmacist.

If Salactol accidentally gets on to normal skin, wipe it off straight away with a tissue, and, if necessary, wash the area.

If Salactol accidentally gets into the eye or is swallowed, go to a hospital Accident & Emergency department straight away.

If you inhale a lot of the vapour from the product it may make you feel light-headed. If this happens, get plenty of fresh air.

If you forget to use Salactol

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Salactol can cause side effects although not everybody gets them:

•    Very rarely unacceptable discomfort or persistent irritation can occur at the treatment area. If this happens, stop using this product and tell your doctor or pharmacist.

•    While the product is working you may feel a slight tingling sensation and / or some mild tenderness at the treated area. This is usually temporary, and in rare cases may appear as a temporary blemish on the skin.

•    If you mistakenly allow the product to spread onto and remain in contact with areas of normal skin, it may cause irritation. If this happens, apply a smaller amount, taking extra care to avoid spreading the product beyond the treatment area.

•    If you spill the product on your clothes, fabrics, jewellery or metal and polished surfaces it may damage them permanently.

If any of the side effects get serious, or if you notice any other side effect not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5.    HOW TO STORE SALACTOL

•    Keep out of the reach and sight of children.

•    Do not use Salactol after the expiry date shown on the bottle, or later than 3 months after opening the bottle for the first time. The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    Always replace the cap tightly after use.

•    Store the bottle upright to avoid spillage.

•    The product is highly flammable. Keep it away from flames or ignition sources.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION ABOUT SALACTOL

What Salactol contains:

The active ingredients are salicylic acid (16.7% w/w) and lactic acid (16.7% w/w).

The other ingredients are pyroxylin, colophony, castor oil, industrial methylated spirit and ether.

What Salactol looks like and contents of the pack

This amber glass bottle contains 10 ml of collodian wart paint. The paint is colourless or pale yellow/brown. The bottle cap incorporates a specially designed applicator spatula.

The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK. The Manufacturer is Aeropak, Viking Road, Great Yarmouth, Norfolk, NR31 0NU, UK.

This leaflet was last revised in May 2015.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Salactol, 00173/5006 This is a service provided by the Royal National Institute of Blind People (RNIB).

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