VASELINE PURE CUVE OINTMENT

Introduction

Package Leaflet: Information for the User

Pure Petroleum Jelly CUVE Ointment

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

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

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

Contents of the Package Leaflet

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

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

Pure Petroleum Jelly CUVE is an ointment that contains petroleum jelly as its active ingredient, which is an emollient and skin protector due to its emollient properties (softening).

It is indicated for symptomatic relief of dryness, mild irritation, and excoriations (abrasions) of the skin.

As a general lubricant.

In use by qualified healthcare personnel: as a lubricant for rectal examinations or application of dressings.

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

Do not use Pure Petroleum Jelly CUVE

• If you are allergic to petroleum jelly (it does not contain excipients).

• In areas of the skin that are infected, inflamed, or have wounds, and in cases of inflammatory skin diseases.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Pure Petroleum Jelly CUVE.

• This medication is for external use only, do not ingest.
• Avoid contact of the medication with the eyes.

In any case, if the discomfort increases during treatment or after 6 days of treatment, or persists after discontinuation, you should consult a doctor.

Children

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

Other Medications and Pure Petroleum Jelly CUVE

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

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

Pregnancy and Breastfeeding

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.

Given the type of medication and the route of administration, this medication can be used during pregnancy.

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 CUVE

Follow the administration instructions for 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: apply a thin layer of the product to the affected area 1 to 3 times a day.

In examinations: apply a thin layer of the product to the area of friction before the examination.

For skin use.

By qualified healthcare personnel: other routes of administration.

If you use more Pure Petroleum Jelly CUVE than you should

Given the type of medication and the route of administration, no cases of intoxication due to overdose associated with the use of petroleum jelly for skin use have been reported.

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.

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 will experience them.

Although no side effects have been observed, some may still occur.

Rarely (may affect up to 1 in 1,000 people), sensitivity reactions have been reported in susceptible individuals.

With an unknown frequency, acne may occur.

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 or pharmacist, even if it is a possible side effect not listed in this package 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 CUVE

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

Do not store at a temperature above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

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6. Package Contents and Additional Information

Composition of Pure Petroleum Jelly CUVE Ointment

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

Appearance of the Product and Package Contents

The ointment has a smooth, translucent, white or almost white appearance.

It is presented in an aluminum tube containing 30 g of ointment.

Marketing Authorization Holder and Manufacturer

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431, Km. 19

Almodóvar del Río - 14720

(Córdoba) - Spain

Date of the Last Revision of this Package Leaflet:September 2021.

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