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Pierre Fabre Santé Glycerol Vaseline Paraffin Cream is a skin protectant.
It provides adjunctive treatment for dry skin associated with certain skin conditions such as atopic dermatitis, ichthyosis, and psoriasis.
Glycerol Vaseline Paraffin Cream increases skin moisture levels with glycerol and restores skin barrier function with petroleum jelly and liquid paraffin. The skin is rehydrated, reducing itching.
This cream is also an adjunctive treatment for minor superficial burns.
The active ingredients are:
Glycerol ...................................... 15.0 g
Petrolatum ....................................... 8.0 g
Liquid Paraffin ............................. 2.0 g
Per 100 g
Other ingredients are: glycerol monostearate, stearic acid, polydimethylcyclosiloxane, dimeticone, macrogol 600, trolamine, propyl parahydroxybenzoate (E216), purified water.
Dosage of Pierre Fabre Glycerol Vaseline Paraffin Cream
The cream should be applied to the skin in a thin layer on the areas to be treated once or twice a day, or more often if necessary.
Precautions for use
This cream should not be used if you are allergic to any of its ingredients, particularly parahydroxybenzoate.
Ask your doctor or pharmacist for advice before taking any medication if you are pregnant or breastfeeding. Keep Glycerol, Vaseline, and Paraffin cream out of reach of children.
You can consult the instructions on our Pharma GDD website, or ask your doctor or pharmacist for advice.
Capacity: 250g tube.
Pierre Fabre Laboratory also offers Cicatryl healing cream in sachets.
LEAFLET
ANSM - Updated on: 07/11/2024
Name of the medicinal product
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2%, cream
Glycerol / Petrolatum / Liquid Paraffin
Box
Please read this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
· You must contact your doctor if you do not feel better or if you feel worse after 30 days.
Keep this medicine out of reach of children.
What is in this leaflet?
1. What is Glycerol/Vaseline/Paraffin Pierre Fabre Santé 15%/8%/2% Cream and what is it used for?
2. What you need to know before you use Glycerol/Vaseline/Paraffin Pierre Fabre Santé 15%/8%/2% Cream?
3. How to use Glycerol/Vaseline/Paraffin Pierre Fabre Santé 15%/8%/2% Cream?
4. Possible side effects?
5. How to store GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2%, cream?
6. Contents of the pack and other information.
1. WHAT IS GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2%, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: OTHER EMOLLIENTS and SKIN PROTECTORS – ATC code: D02AX.
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE acts on the skin by increasing its hydration level, thanks to glycerol, and by restoring the skin's barrier function, thanks to petroleum jelly and liquid paraffin. GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE thus allows the skin to regain its hydration and protective role, reducing irritation, itching, and scratching.
The active ingredients in GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE are: glycerol, petrolatum, and liquid paraffin.
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE, an emollient (softens the skin) and moisturizing cream, combats dry skin.
This medication is recommended for adults and children, including infants:
· As an adjunctive treatment for dry skin associated with certain skin conditions such as atopic dermatitis, ichthyosis (very dry and rough skin associated with the presence of dead skin that flakes off), and psoriasis.
· as an adjunct treatment for minor superficial burns.
You should consult your doctor if you do not feel better or if you feel worse after 30 days.
2. WHAT YOU NEED TO KNOW BEFORE USING GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2% CREAM?
Never use GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE:
If you are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE.
Do not swallow.
It is recommended not to apply GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE to an infected lesion or under an occlusive dressing.
Children
Not applicable.
Other medicines and GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE with food and drink
Not applicable.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE can be used during pregnancy and breastfeeding.
It is recommended not to apply GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE to the breast during breastfeeding to avoid the risk of ingestion by the child.
Athletes
Not applicable.
Driving and operating machinery
Not applicable.
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE contains propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
3. HOW TO USE GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2%, cream?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
For cutaneous use only, for external use only.
For adults and children, including infants, apply a thin layer of the cream to the areas to be treated once or twice a day, or more often if necessary.
Pediatric population
Do not apply to premature infants.
If you use more GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE than you should:
Not applicable.
If you forget to use GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE:
Not applicable.
If you stop using GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Uncommonly reported side effects (affecting less than 1 in 100 patients) include hives, itching, redness, eczema, rash, and application site reactions (irritation, redness, pain, or itching).
Other side effects of unknown frequency (frequency cannot be estimated from the available data) may occur, such as application site eczema and burning sensation of the skin.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers – Website: https://signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you help provide more information on the safety of this medicine.
5. HOW TO STORE GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2%, cream?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Keep the tube tightly closed.
After first opening the tube, the medicine should be stored for a maximum of 6 months.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What PIERRE FABRE SANTE GLYCEROL/PETROLEUM VASELINE/PARAFFIN 15%/8%/2% contains (cream)
The active ingredients are: glycerol, petrolatum, liquid paraffin.
Each gram of PIERRE FABRE SANTE GLYCEROL/PETROLEUM VASELINE/PARAFFIN contains 0.15 g of glycerol, 0.08 g of petrolatum, and 0.02 g of liquid paraffin.
The other ingredients are:
Glycerol monostearate, stearic acid, polydimethylcyclosiloxane, dimeticone, macrogol 600, trolamine, propyl parahydroxybenzoate (E216)*, purified water.
*See section 2 "GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE contains".
What GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE 15%/8%/2% cream looks like and what are the contents of the outer packaging?
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE is a smooth, white cream for cutaneous application.
GLYCEROL/PETROLEUM VASELINE/PARAFFIN PIERRE FABRE SANTE is available in 50, 100, 150, or 250 g low-density polyethylene tubes.
Not all pack sizes 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
PROGIPHARM SITE
RUE DU LYCEE
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[to be completed later by the holder]
Other
Detailed information on this medicinal product is available on the ANSM website (France)
