SALICYL VASELIN

SALICYL VASELIN 10% Ointment

Important notes (mandatory information)

Salicyl Vaseline 10%, ointment. Active ingredient: Salicylic acid. Areas of application: is used externally for increased callus formation (hyperkeratosis), corns (clavus), calluses (callus).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Salicyl Vaseline 10%, ointment for application to the skin for use in children from 1 year of age and adults
Active ingredient: Salicylic acid

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, in order to achieve the best possible treatment results, this medicine must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve, you must see a doctor in any case.

This package leaflet contains

1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING THIS MEDICINE?
3. HOW TO USE THIS MEDICINE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE THIS MEDICINE?
6. FURTHER INFORMATION

1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?

Salicyl Vaseline 10% is a keratolytic agent. This ointment is used externally for increased callus formation (hyperkeratosis), corns (clavus), calluses (callus).

2. WHAT DO YOU NEED TO KNOW BEFORE USING THIS MEDICINE?

This medicine must not be used:

• if you are hypersensitive (allergic) to salicylic acid or any of the other ingredients of Salicyl Vaseline 10%,
• in case of contact hypersensitivity,
• during pregnancy,
• in infants,
• in case of impaired renal function.

Special care must be taken when using this medicine if the symptoms described in section 1 worsen. In this case, consult your doctor or pharmacist.

Children

Do not use Salicyl Vaseline 10% on infants.

When using this medicine with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines. Salicylic acid can increase the absorption of other medicines applied to the same area. Salicylic acid absorbed by the body delays the breakdown of methotrexate and enhances the effect of sulfonylureas.

Pregnancy and breast-feeding

Do not use Salicyl Vaseline 10% during pregnancy. During breast-feeding, Salicyl Vaseline 10% must not be used in the breast area. Breastfeeding women may use Salicyl Vaseline 10% to treat corns only for areas up to 5 cm². Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

There is no experience regarding impairment of the ability to drive and use machines.

3. HOW TO USE THIS MEDICINE?

Always use Salicyl Vaseline 10% exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Dosage and method of administration

Children from 1 year of age: Maximum daily dose of ointment not more than 2 g, maximum daily dose of active ingredient less than 0.2 g. Adults: Maximum daily dose of ointment less than 20 g, maximum daily dose of active ingredient less than 2.0 g. Apply Salicyl Vaseline 10% to the skin once or twice a day.

Duration of use

Do not use Salicyl Vaseline 10% for more than 7 days without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Salicyl Vaseline 10% is too strong or too weak.

If you have used a larger amount of the medicine than you should and experience symptoms due to the higher dose, please notify your doctor. He/she can decide on any necessary measures. The side effects listed may occur more frequently.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Salicyl Vaseline 10%

can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Skin irritation may occur at the sites where Salicyl Vaseline 10% was applied. In very rare cases, a previously unknown hypersensitivity reaction (contact sensitization) to salicylic acid may occur.

Special notes

Do not continue to use Salicyl Vaseline 10% if you experience any of the above side effects.

Reporting of side effects

If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE THIS MEDICINE?

General information: Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the tube and the carton after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C. Store tightly closed in the original container.

6. FURTHER INFORMATION

What this medicine contains

100 g of ointment contain the active ingredient: 10 g of salicylic acid. The other ingredients are: liquid paraffin, white petrolatum.

What the medicine looks like and contents of the pack

Salicyl Vaseline 10% is available in the following pack size: 100 ml ointment in a tube in a cardboard box.
This medicine is available in another strength: Salicyl Vaseline 5% 100 ml ointment in a tube in a cardboard box.

Pharmaceutical entrepreneur/manufacturer

Bombastus-Werke AG
Wilsdruffer Straße 170
01705 Freital
Germany
Phone: +49 351 65803-0
Fax: +49 351 65803-99
E-mail: info@bombastus-werke.de

This leaflet was last revised in April 2014.

Source: Package leaflet information
Status: 03/2017
Active ingredient: Salicylic acid. Areas of application: is used externally for increased callus formation (hyperkeratosis), corns (clavus), calluses (callus).