ALCOHOL 96% SANITARIO REIG JOFRE CUTANEOUS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Surgical Alcohol 96º Reig Jofre skin solution

Alcohol 96º

Read the package leaflet carefully before starting to use this medicine because it contains important information

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 2 days.

Contents of the package leaflet

1. What is Surgical Alcohol 96º and what is it used for
2. What you need to know before starting to use Surgical Alcohol 96º
3. How to use Surgical Alcohol 96º
4. Possible side effects
5. Storage of Surgical Alcohol 96º

1. Contents of the pack and further information

1. What is Surgical Alcohol 96º and what is it used for

Surgical Alcohol 96º is an antiseptic used for skin disinfection.

You should consult a doctor if it worsens or does not improve after 2 days.

2. What you need to know before starting to use Surgical Alcohol 96º

Do not use Surgical Alcohol 96º

• If you are allergic to alcohol.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Surgical Alcohol.

Do not apply to deep and extensive wounds.

Protect from heat. Highly flammable. Keep the container tightly closed.

Do not use this medicine near an open flame, lit cigarettes, or certain devices (e.g., hair dryers).

Do not come into contact with mucous membranes, it is highly irritating.

Prolonged use may cause irritation and dryness of the skin.

It may cause contact dermatitis.

Avoid contact with the eyes. If accidental contact with the eyes occurs, rinse abundantly with water and consult an ophthalmologist if necessary.

The solution is flammable.

The risk of fire is high when using an ignition source (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with a combustion source (such as cloths, towels...) and an oxidizing agent (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

• Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
• Remove any soaked material, gauzes, or gowns before starting the procedure.
• Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Surgical Alcohol 96º, take special care to ensure there is no excess product before applying the dressing.

• Reduce the supply of oxygen or any other oxidizing agent to the minimum necessary. Those procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizing agent put the patient at risk of suffering a surgical fire.

Surgical Alcohol 96º contains alcohol (ethanol)

This medicine contains 74.88 g of alcohol (ethanol) per 100 ml. It may cause a burning sensation on damaged skin.

3. How to use Surgical Alcohol 96º

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Topical use. For external use only. DO NOT INGEST.

Apply directly to the area to be treated, let it act for 2 minutes before each procedure.

It is recommended to wash your hands after each application.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

No side effects have been reported.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Surgical Alcohol 96º

Keep this medicine out of the sight and reach of children.

Flammable. Avoid exposing the bottle and its contents to open flames during use, storage, and disposal of the product.

Do not store above 30°C. It is highly flammable. Store in the original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of 100 ml of Surgical Alcohol 96º:

The active ingredient is ethanol 96% (alcohol 96º). Each ml of solution contains 1 ml of ethanol at 96% (alcohol 96º). Each 100 ml of solution contains 100 ml of ethanol at 96% (alcohol 96º).

Pack contents:

It is presented in a high-density polyethylene container with a dropper cap.

Further information

In the absence of compatibility studies, this medicine must not be mixed with others.

Marketing authorization holder and manufacturer

LAB. REIG JOFRE, S.A.

C/ Gran Capitán 10

08970 Sant Joan Despí (Barcelona)

Spain

or

Pharmex Advanced Laboratories, SL

Ctra. A-431 Km. 19

Almodóvar del Río, 14720 - Córdoba

Date of last revision of this package leaflet: July 2024

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.