Label: information for the user

Pure Vaseline Brum ointment

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

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 6 days.

1. What is Pure Vaseline Brum and what it is used for

2. What you need to know before starting to use Pure Vaseline Brum

3. How to use Pure Vaseline Brum

4. Possible adverse effects

5. Storage of Pure Vaseline Brum

6. Contents of the container and additional information

Pure Brum Vaseline is a balm that contains vaseline as its active ingredient, which is a moisturizer.

It is indicated as a skin protector due to its emollient properties (softening), and can be used to relieve symptoms of dry, cracked, and irritated skin.

As a general lubricant.

For use by qualified healthcare personnel: as a lubricant in examinations, application of dressings.

Do not use Pure Brum Vaseline:

• If you are allergic to Vaseline.
• In infected or injured areas, or in inflammatory skin diseases.
• On skin with acne and oiliness.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Pure Brum Vaseline.

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

Children

No data is available for use in children.

Other medications and Pure Brum Vaseline

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

Pregnancy and breastfeeding

This medication can be used during pregnancy.

Do not apply the medication to the nipples if breastfeeding a baby.

Driving and operating machines

Not applicable.

Follow exactly the administration instructions of the medication contained in this leaflet or those 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.

During examinations: Apply a thin layer of the product to the friction area before the examination.

Cutaneous use.

By qualified healthcare personnel: other routes of administration.

If you use more Pure Brum Petroleum Jelly than you should

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

With the use of excessive doses on mucous membranes (such as the nasal passages) there could be leakage or aspiration, with adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Reactions of hypersensitivity have occurred in susceptible individuals on rare occasions.

Also reported: acne and inflammatory reactions following non-indicated use.

On rare occasions, allergic reactions may occur in sensitive individuals.

Frequency unknown, acne may occur.

Reporting 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 prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

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

This product does not require special storage conditions.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Pure Brum Petroleum Jelly Composition

• The active ingredient is petroleum jelly. 1 g of ointment contains 1 g of petroleum jelly.
• It does not contain excipients.

Product appearance and packaging contents

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

It is presented in an aluminum tube with a printed label containing 30 g or 60 g of ointment.

Marketing authorization holder and manufacturer responsible

Laboratorios Brum, S.A.

C/ Quevedo, 4

33012 – Oviedo (Asturias)

Last review date of this leaflet:August 2016.

Detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

(AEMPS)http://www.aemps.gob.es/.