VASELINE PURE PETROLEUM JELLY

Introduction

Package Leaflet: Information for the User

Pure Petroleum Jelly Pege Ointment

(Pure Filante Petroleum Jelly)

Read the entire package 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 package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 6 days.

Contents of the Package Leaflet

1. What is Pure Petroleum Jelly Pege and what is it used for
2. What you need to know before starting to use Pure Petroleum Jelly Pege
3. How to use Pure Petroleum Jelly Pege
4. Possible side effects
5. 5 Conservation of Pure Petroleum Jelly Pege
6. Package Contents and Additional Information

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

Pure Petroleum Jelly Pege is a moisturizing ointment.

It is indicated for the symptomatic relief of dry, cracked, irritated skin, and burns.

As a lip moisturizer. Skin protector.

In use by qualified healthcare personnel: As a lubricant in general in gynecological and rectal examinations, catheter placement, and dressing application.

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

Do not use Pure Petroleum Jelly Pege

• If you are allergic to petroleum jelly.

Warnings and Precautions

• Consult your doctor or pharmacist before using Pure Petroleum Jelly Pege.
• It is a medication for external use only.
• Avoid contact with the eyes.
• Do not ingest.

Children and Adolescents

Pure Petroleum Jelly Pege can be used in children as a moisturizer.

Use in examinations should be supervised by qualified healthcare personnel.

Using Pure Petroleum Jelly Pege with Other Medications

Tell your doctor or pharmacist that you are using or have recently used other medications.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and Using Machines

The use of this medication does not affect the ability to drive and use machines.

3. How to Use Pure Petroleum Jelly Pege

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

The recommended dose is:

• On the skin and lips:

Topical use.

Apply a thin layer of the product to the affected area 2 or 3 times a day, if necessary.

• In gynecological and rectal examinations (by qualified healthcare personnel):

Apply a thin layer of the product to the friction area before each examination.

Use in Children and Adolescents

Apply as indicated above.

If You Use More Pure Petroleum Jelly Pege Than You Should

No cases of intoxication have been reported if you use more petroleum jelly than indicated.

With excessive doses in the rectum, anal leakage and irritation may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 Forget to Use Pure Petroleum Jelly Pege

Do not apply a double dose to make up for forgotten doses.

If You Interrupt Treatment with Pure Petroleum Jelly Pege

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

4. Possible Side Effects

Like all medications, Pure Petroleum Jelly Pege can cause side effects, although not everyone will experience them.

Isolated cases of allergy (sensitivity reaction) have occurred in susceptible individuals; acne may also occur. Inflammatory reactions have been reported after absorption.

Reporting 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 Medication Surveillance System for Human Use. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Pure Petroleum Jelly Pege

No special storage conditions are required.

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

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

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pure Petroleum Jelly Pege

• The active ingredient is pure filante 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 a white, translucent, greasy mass to the touch.

It is presented in an aluminum tube with 5 g and 33 g of ointment.

Marketing Authorization Holder and Manufacturer

LABORATORIOS BOHM, S.A.

C/ Molinaseca 23. Polígono Industrial Cobo Calleja.

28947 Fuenlabrada (Madrid)

Spain

Date of the Last Revision of this Package Leaflet:April 2013.

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/