NOTICE
ANSM - Updated on : 11/07/2024
Product name
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream
Glycerol / Vaseline / Liquid kerosene
Box
Please read this leaflet carefully before using this medicine as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- Contact your doctor if you do not feel better or feel worse after 30 days.
Keep out of the reach of children.
What does this leaflet contain?
1. What is GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream and what is it used for?
2. What do I need to know before using GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream?
3. How do I use GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream?
4. What are the possible side effects?
5. How to store GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream?
6. Package contents and other information.
1. WHAT IS GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER EMOLLIENTS and SKIN PROTECTANTS ATC code: D02AX.
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE acts on the skin by increasing its moisture level, thanks to glycerol, and by restoring the skin's barrier function, thanks to vaseline and liquid kerosene. GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE helps skin regain its moisture levels and protective role, and reduces irritation, itching and scratching.
The active ingredients in GLYCEROL/VASELINE/PARAFFIN PIERRE FABRE SANTE are glycerol, vaseline and liquid kerosene.
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE, emollient (skin-softening) and moisturizing cream, combats dry skin.
Recommended for adults and children, including infants:
- as an adjunct treatment for dry skin accompanying certain skin conditions such as atopic dermatitis, ichthyosis (very dry, rough skin with dead skin flakes) and psoriasis.
- as an adjunct treatment for superficial burns over small areas.
You should consult your doctor if you do not feel any improvement or if you feel worse after 30 days.
2. WHAT DO I NEED TO KNOW BEFORE USING GLYCEROL/VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2%, CREME?
Never use GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE :
If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE.
Do not swallow.
It is recommended not to apply GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE to an infected lesion or under an occlusive dressing.
Children
Not applicable.
Other medicinal products and GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE with food and drink
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE may be used during pregnancy and while breast-feeding.
It is recommended not to apply GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE to the breast while breast-feeding to avoid the risk of GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE being swallowed by the child.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE contains propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
3. HOW TO USE GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For external use only.
In adults and children, including infants, apply the cream in a thin layer to the areas to be treated, once or twice a day, or more if necessary.
Pediatric population
Do not apply to premature infants.
If you have used more GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE than you should have :
Not applicable.
If you forget to use GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE :
Not applicable.
If you stop using GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but they do not occur systematically in everyone.
Infrequently reported side effects (occurring in less than 1 in 100 patients) include urticaria, itching, redness, eczema, rash and application site reactions (irritation, redness, pain or itching).
Other effects of undetermined frequency (cannot be estimated on the basis of available data) may occur, such as eczema at the application site and burning sensation of the skin.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This applies to any side effect not mentioned in this leaflet. You can also report any adverse reaction directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers Website: https: //signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton. The expiration date refers to the last day of that month.
Keep tube tightly closed.
After first opening the tube, the medicine should be stored for a maximum of 6 months.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2% cream contains
- The active ingredients are glycerol, petroleum jelly and liquid kerosene.
Each gram of GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE contains 0.15 g glycerol, 0.08 g vaseline and 0.02 g liquid kerosene.
- Other components include
Glycerol monostearate, stearic acid, polydimethylcyclosiloxane, diméticone, macrogol 600, trolamine, propyl parahydroxybenzoate (E216)*, purified water.
*See section 2 "GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE contains".
What is GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE 15%/8%/2%, cream and what does it contain?
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE is a smooth white cream for cutaneous application.
GLYCEROL/VASELINE/PARAFFINE PIERRE FABRE SANTE comes in 50, 100, 150 or 250 g low-density polyethylene tubes.
Not all presentations may be marketed.
Marketing authorization holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing authorization holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website