VASELINE PURE REIG JOFRE OINTMENT

Introduction

Leaflet: information for the user

Pure Petroleum Jelly Reig Jofre ointment

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as 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 or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 6 days.

Contents of the leaflet

1. What is Pure Petroleum Jelly Reig Jofre and what is it used for
2. What you need to know before starting to use Pure Petroleum Jelly Reig Jofre
3. How to use Pure Petroleum Jelly Reig Jofre
4. Possible side effects
5. Storage of Pure Petroleum Jelly Reig Jofre
6. Package contents and additional information

1. What is Pure Petroleum Jelly Reig Jofre and what is it used for

It is a moisturizing ointment.

Pure Petroleum Jelly Reig Jofre is indicated for: Symptomatic relief of dry, cracked, and irritated skin. As a protector and moisturizer of the skin due to its emollient properties (softening).

In use by qualified healthcare personnel: as a lubricant in general in gynecological and rectal examinations, placement of probes, and application of dressings.

2. What you need to know before starting to use Pure Petroleum Jelly Reig Jofre

Do not use Pure Petroleum Jelly Reig Jofre:

• If you are allergic to petroleum jelly.
• In infected or wounded areas.

Warnings and precautions

Consult your doctor or pharmacist before using Pure Petroleum Jelly Reig Jofre.

• It is a medication exclusively for external use. Do not ingest.
• Avoid contact with the eyes.

Children and adolescents

This medication can be used in children on the skin.

In use during examinations, there is no data available for children.

Use of Pure Petroleum Jelly Reig Jofre with other medications

The use of this medication does not interact with the use of other medications.

Pregnancy and breastfeeding

This medication can be used during pregnancy on the skin.

Do not apply the medication to the breasts if you are breastfeeding a baby.

Driving and using machines

Not applicable.

3. How to use Pure Petroleum Jelly Reig Jofre

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• On the skin: Apply a thin layer of petroleum jelly to the affected area one to three times a day.
• In gynecological and rectal examinations (by qualified healthcare personnel): Apply a thin layer of the product to the friction area before the examination.

If you use more Pure Petroleum Jelly Reig Jofre than you should

No side effects have been reported when using a thin layer of petroleum jelly on the skin.

With excessive use on mucous membranes (such as in the nasal passages), filtration or aspiration may occur, with side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested (or go to a medical center).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Rarely, sensitivity reactions have occurred in susceptible individuals.

Acne and inflammatory reactions after absorption due to non-indicated use have also been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pure Petroleum Jelly Reig Jofre

Store below 30°C.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Pure Petroleum Jelly Reig Jofre

• The active ingredient is petroleum jelly.
• It does not contain excipients.

Appearance of the product and package contents

The product is presented in the form of an ointment; it is white, greasy to the touch.

It is presented in an aluminum tube with screen printing containing 18 g, 25 g, or 32 g of ointment.

Marketing authorization holder

Reig Jofré Laboratory, S.A.

Gran Capitán Street, 10

08970 - Sant Joan Despí (Barcelona)

Spain

Manufacturer

BIOGLAN AB

Box 503 10

SE-202 13 Malmö

Sweden

Date of the last revision of this leaflet:March 2025.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/.