Salicylol
Poland
Table of Contents
Package leaflet: information for the patient
SALICYLOL, Acidum salicylicum + Ricini oleum virginale,
(50 mg + 950 mg)/g, topical solution
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
1. What SALICYLOL is and what it is used for
2. Important information before using SALICYLOL
3. How to use SALICYLOL
4. Possible side effects
5. How to store SALICYLOL
6. Contents of the pack and other information
1. What SALICYLOL is and what it is used for
SALICYLOL is an oily solution of salicylic acid, with antibacterial, antifungal, and mild keratolytic action, i.e., it dissolves the stratum corneum.
It is particularly indicated for the treatment of seborrhoeic dermatitis manifested by persistent dandruff, fungal infections such as superficial tinea capitis (fungal infection of the scalp), inflammatory tinea of the scalp, and pityriasis versicolor. It may also be used as an adjunct in acne treatment.
2. Important information before using SALICYLOL
When not to use SALICYLOL:
- if you are allergic to salicylic acid or castor oil,
- in children under 3 years of age,
- in acute inflammatory skin conditions,
- on open wounds,
- on large areas of skin,
- on mucous membranes of eyes, mouth, and nose – in case of contact with mucous membranes, rinse thoroughly with warm water.
Warnings and precautions
Before starting treatment with SALICYLOL, consult your doctor or pharmacist.
Children
Do not use in children under 3 years of age.
SALICYLOL and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Do not use simultaneously with topical preparations containing resorcinol or rivanol, as chemical reactions may occur between salicylic acid and these components.
Use of SALICYLOL with food and drink
No effect.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
SALICYLOL has no effect on the ability to drive motor vehicles or operate mechanical equipment.
3. How to use SALICYLOL
This medicine should always be used exactly as described in this patient information leaflet, or
as advised by your doctor or pharmacist. If in doubt, consult your doctor or
pharmacist.
Unless otherwise prescribed by a doctor, the medicine is usually used as described
below.
Adults and children over 3 years of age
Apply the medicine by rubbing it into the affected areas of the scalp using a cotton pad soaked with the product, parting the hair. Wash the hair 1–2 hours after application. Repeat the procedure several times, with intervals of 3–4 days.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or
pharmacist.
Use of more than the recommended dose of SALICYLOL
There is no data available regarding overdose with this medicine when used topically.
Missed application of SALICYLOL
Do not use a double amount to make up for a missed application. Continue treatment as usual.
Stopping treatment with SALICYLOL
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During treatment, skin allergic reactions may occur. If such symptoms occur, treatment should be discontinued and medical advice sought.
In some individuals, other adverse reactions may occur during use of the medicine SALICYLOL. If any other adverse effects not listed in this leaflet occur, inform your doctor about them.
Reporting of adverse reactions:
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store SALICYLOL
Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the packaging and other information
What SALICYLOL contains
The active substances in the medicine are salicylic acid and first-pressed castor oil.
What SALICYLOL looks like and contents of the pack
Packaging
An amber glass bottle fitted with a screw cap made of high-density polyethylene, containing
100 g of the medicine. The bottle, together with the package leaflet, is placed in a printed
cardboard carton.
Marketing Authorisation Holder and Manufacturer:
Pharmaceutical and Cosmetic Production Enterprise „PROFARM” Sp. z o.o.
ul. Słupska 18
84-300 Lębork
tel./fax (59) 862 72 40
[email protected]
For further information about this medicine, please contact the Marketing Authorisation Holder:
Pharmaceutical and Cosmetic Production Enterprise „PROFARM” Sp. z o.o.
ul. Słupska 18
84-300 Lębork
tel./fax (59) 862 72 40
[email protected]
16-05-2025