Alcohol 96º sanitario Reig Jofre cutaneous solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alcohol 96º sanitario Reig Jofre cutaneous solution

Alcohol 96º

Read all of this leaflet carefully before starting to use this medicine, because it contains important information

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 2 days.

Leaflet contents

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

2. What you need to know before using Alcohol 96º sanitario

3. How to use Alcohol 96º sanitario

4. Possible adverse effects

5. Storage of Alcohol 96º sanitario

6. Contents of the container and other information

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

Alcohol 96º is an antiseptic used for disinfecting the skin.

Consult a doctor if symptoms worsen or do not improve after 2 days.

2. What you need to know before using Alcohol 96º sanitario

Do not use Alcohol 96º sanitario

• If you are allergic to alcohol.

Warnings and precautions

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

Do not apply to deep or extensive wounds.

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

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

Do not allow contact with mucous membranes, as it is highly irritating.

Prolonged use may cause skin irritation and dryness.

May cause contact dermatitis.

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

The solution is flammable.

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

To reduce the risk of fire:

• Do not perform electrocautery or use other ignition sources until the skin is completely dry.
• Remove any soaked materials, gauze, or surgical gowns before beginning the procedure.
• Do not use excessive amounts and avoid accumulation of the solution in skin folds, under the patient, or soaking into sheets or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to Alcohol 96º Sanitario, 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. Procedures performed on the head, neck, and upper chest (above T5), along with the use of an ignition source near an oxidizing agent, place the patient at risk of a surgical fire.

Sanitary 96º alcohol contains alcohol (ethanol)

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

3. How to use Sanitary 96º Alcohol

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

It is recommended to wash hands after each application.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

No side effects have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sanitary 96º Alcohol

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. This product 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 container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition per 100 ml of Sanitary 96% Alcohol:

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

Contents of the container:

Supplied in a high-density polyethylene container with a dropper cap.

Additional information

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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 the most recent review of this leaflet: July 2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.