BEPANTHEN 5% Ointment 100 grams by BAYER is an over-the-counter medication indicated for the treatment of diaper rash in infants, babies, and children.
Available individually or in a 2-pack.
For warnings, precautions, and contraindications, please refer to the package insert for Bepanthen ointment.
This over-the-counter medication is recommended for treating skin irritation, such asdiaper rash (red bottom), in infants. Effective at the first signs of diaper rash, Bepanthen Ointment is formulated specifically for babies’ skin. Bepanthen Ointmentrepairs, soothes, and protectstoddlers’ irritated bottoms while allowing their skin to breathe and preventing maceration. Bepanthen Ointment contains 5% dexpanthenol.
An ointment is primarily formulated with fatty substances (known as a water-in-oil emulsion). This ointment is generally used on moist lesions.
During their first year of life, few babies escape “red bottom” or diaper rash. Friction from the diaper, skin maceration, changing diapers too infrequently… These are all factors that contribute to the onset of this irritation, which, while certainly benign, can quickly become frustrating for both the baby and mom.
With Bepanthen ointment, discover here the right steps and habits that will soothe your little one’s red, irritated skin.
In practice, apply Bepanthen ointment with a gentle massage at every diaper change, as soon as you notice the first signsof diaper rash.
The creamy texture of Bepanthen Ointment allows for a gentle application.
Bepanthen Ointment isn’t sticky, so it can be easily wiped away.
Bepanthen ointment doesn’t mask the irritated areas after application, allowing you to monitor their treatment effectively.
Remember to change your child’s diaper regularly, especially after a bowel movement, to preventdiaper rash from recurring.
Bepanthen Ointment is tailored to the specific needs of your baby’s skin. You can use it once or several times a day, especially during diaper changes.
* An active ingredient that promotes healing: Dexpanthenol (or provitamin B5), which provides the nutrients necessary for skin regeneration.
* An oily base containing an excipient, Protegin X, which protects your baby’s bottom from external irritants (urine, stool, friction).
Within cells, dexpanthenol is rapidly converted into pantothenic acid, which plays a key role as a component of coenzyme A. As part of the cellular repair process, it promotes cell regeneration and the repair of the skin’s epithelium.
Bepanthen Ointment, with its semi-occlusive consistency, also allows your baby’s skin to breathe. Ointments that are too occlusive can cause maceration, which worsens irritation in your baby’s diaper area. With its specific formula, Bepanthen Ointment allows your baby’s skin to breathe, thereby promoting skin repair.
Bepanthen Ointment features a unique formula well-suited to babies’ delicate skin.
What are the side effects and contraindications?
Bepanthen® Ointment should not be used in cases of infected or weeping skin conditions or in cases of known hypersensitivity to any of its ingredients.
BEPANTHEN 5%, Dexpanthenol Ointment, SKIN PROTECTOR.
Therapeutic Indications
This medication is indicated for the treatment of skin irritation, particularly in cases of diaper rash (red bottom) in infants.
Pregnancy and breastfeeding
This medication should be used with caution during pregnancy and breastfeeding. For breastfeeding women, if applied to the breasts, clean the skin before each feeding.
In general, you should consult your doctor or pharmacist before taking any medication.
Instructions for Proper Use
Dosage, Method and/or Route(s) of Administration, Frequency of Administration, and Duration of Treatment
Dosage
Storage Conditions
Store at a temperature not exceeding 25°C.
If necessary, warnings regarding certain visible signs of deterioration
The active ingredient is:
Dexpanthenol 5.0 g
Per 100 g of ointment.
The other ingredients are: Protegin X, petroleum jelly, lanolin, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.
Dosage form and contents.
What are the side effects and contraindications?
Never use BEPANTHEN 5% ointment in the following cases:
IF IN DOUBT, IT IS ESSENTIAL TO CONSULT YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take care when using BEPANTHEN 5% ointment:
Keep out of the reach and sight of children.
Expiration Date: Do not use BEPANTHEN 5% ointment after the expiration date printed on the outer packaging. If there is no improvement after 5 days despite strictly following the health advice, consult a doctor or ask a pharmacist for advice.
This over-the-counter medication comes in the form of an ointment.
Available in tubes of 3.5 g, 30 g, 80 g, or 100 g.
Skin irritations result from a disruption of the skin’s natural protective barrier, leading to redness, which may be accompanied by peeling or cracking of the skin. They are caused by irritants such as cold, mechanical friction, or chemicals...
Diaper rash in infants is skin irritation in the areas covered by diapers. The skin becomes red and then cracks.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 30/05/2024
Product name
BEPANTHEN 5%, ointment
Dexpanthenol
Sidebar
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 advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is BEPANTHEN 5%, ointment and what is it used for?
2. What do I need to know before using BEPANTHEN 5%, ointment?
3. How do I use BEPANTHEN 5% Ointment?
4. What are the possible side effects?
5. How should BEPANTHEN 5% Ointment be stored?
6. Package contents and other information.
1. WHAT IS BEPANTHEN 5%, ointment AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - CUTANEOUS PROTECTANT ATC code: D03AX. (D: dermatology).
This medicine is indicated for the treatment of skin irritation, particularly diaper rash (red bottom) in infants.
You should contact your doctor if you do not feel any improvement or if you feel worse after 5 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING BEPANTHEN 5%, ointment?
Never use BEPANTHEN 5%, ointment :
- if you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- if you have an infected or oozing dermatitis.
Warnings and precautions
Talk to your doctor or pharmacist before using BEPANTHEN 5%, ointment.
Avoid contact with eyes, as this may cause irritation.
Children and teenagers
Not applicable.
Other medicinal products and BEPANTHEN 5%, ointment
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
BEPANTHEN 5%, ointment with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This drug should be used with caution during pregnancy and lactation. If applied to the breasts of nursing mothers, cleanse the skin before each feed.
Driving and using machines
Not applicable.
BEPANTHEN 5% ointment contains lanolin (wool fat), stearyl alcohol and cetyl alcohol:
This medicine may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE BEPANTHEN 5%, ointment?
Always use this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is one to several applications per day. Apply by massaging gently. Apply to the skin.
If you have used more BEPANTHEN 5%, ointment than you should have
Not applicable.
If you forget to use BEPANTHEN 5%, ointment
Not applicable.
If you stop using BEPANTHEN 5%, ointment
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE BEPANTHEN 5%, ointment?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the outer packaging after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding +25°C.
Do not dispose of any medicine in the drain or with 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 BEPANTHEN 5% ointment contains
- The active substance is :
Dexpanthenol................................................................................................................... 5.0 g
Per 100 g of ointment
- Other ingredients are :
Protegin X®, vaseline, wool grease, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid kerosene, purified water.
What BEPANTHEN 5% ointment is and what it contains
This medicine comes in the form of an ointment.
Tube of 3.5 g, 30 g, 80 g and 100 g.
Marketing authorization holder
BAYER HEALTHCARE
1 RUE CLAUDE BERNARD
59000 LILLE
Marketing authorization holder
BAYER HEALTHCARE
33, RUE DE LINDUSTRIE
74240 GAILLARD
Manufacturer
GRENZACH PRODUKTIONS GMBH
EMIL BARELL STRASSE 7
79639 GRENZACH-WHYLEN
GERMANY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on theANSM France website.
Health education advice:
Cutaneous irritations correspond to an alteration in the skin's natural protective barrier leading to redness, possibly associated with peeling or cracking of the skin. They are due to the action of irritants such as cold, mechanical friction, chemicals, etc.
Infant diaper rash is an irritation of the skin around the diaper area. The skin is red and then cracks.
- How can I prevent diaper rash? "
To prevent diaper rash, keep your baby's bottom clean, dry and cool.
Change your baby's diaper often, and leave the bottom open to the air as much as possible. This allows the skin to dry out.
At each diaper change, clean your baby's bottom thoroughly with lukewarm (but not hot) water, not forgetting the little folds.
Let the bottom dry thoroughly before putting on another diaper, preferably in the open air or with a clean absorbent towel, without rubbing to avoid irritation.
- What to do in case of diaper rash? "
Avoid fitting diapers too tightly, so as to let your baby's skin "breathe".
Leave your baby without a diaper as much as possible. Fresh air dries out moist, irritated skin and helps the rash to heal.
Apply a protective, repairing ointment to your child's bottom after every diaper change.
C'est une pommade protectrice et adoucissante qui contient de la vitamine B5.
Elle est utilisée pour traiter les irritations de la peau, notamment les rougeurs des fesses du nourrisson.
Les prix mentionnés ne tiennent pas compte des « honoraires de dispensation » du pharmacien.
| p 100 g | |
| Dexpanthénol (vitamine B5) | 5 g |
| Alcool cétylique | + |
| Alcool stéarylique | + |
| Lanoline | + |
Cette pommade peut être utilisée pendant la grossesse ou l'allaitement.
En cas d'application sur le sein pendant l'allaitement, nettoyer le mamelon avant chaque tétée.
Nettoyer la peau et appliquer la pommade en massant légèrement.
Une ou plusieurs applications par jour.
La rougeur des fesses du nourrisson est souvent due à l'imprégnation de la peau par l'urine, sous la couche. Il est donc nécessaire de nettoyer et de rincer abondamment la peau avec de l'eau avant d'appliquer le médicament.
Ce médicament peut être en accès libre (ou accès direct) dans certaines pharmacies ; dans ce cas, faites valider votre choix par votre pharmacien.
Rares : eczéma de contact (présence de lanoline, d'alcool stéarylique et d'alcool cétylique).
Nom général désignant une famille de substances qui ont la propriété de pouvoir être mélangées à l'eau et aux corps gras. L'alcool le plus courant est l'alcool éthylique (éthanol), mais il existe de nombreux autres alcools : méthanol, butanol, etc. Le degré d'une solution alcoolique correspond au volume d'alcool pur présent dans 100 ml de solution, en sachant que 1 verre ballon de vin ou 1 demi de bière (25 cl) contiennent environ 8 g d'alcool.
Lorsque l'alcool est utilisé comme antiseptique, un dénaturant d'odeur désagréable lui est souvent ajouté pour éviter qu'il soit bu. Contrairement à une croyance répandue, l'alcool à 70° (ou même à 60°) est un meilleur antiseptique que l'alcool à 90°.
Consultez l'article : Alcoolodépendance
Réaction cutanée (démangeaisons, boutons, gonflement) ou malaise général apparaissant après un contact avec une substance particulière, l'utilisation d'un médicament ou l'ingestion d'un aliment. Les principales formes d'allergie sont l'eczéma, l'urticaire, l'asthme, l'œdème de Quincke et le choc allergique (choc anaphylactique). L'allergie alimentaire peut également se traduire par des troubles digestifs.
Maladie de la peau se manifestant par des boutons et de vives démangeaisons. L'eczéma peut être dû au contact avec une substance allergisante (eczéma de contact) ou être lié à une prédisposition génétique (eczéma atopique).
Consultez l'article : Dermatite atopique (eczéma atopique)
Enfant de un à 30 mois. Un enfant de moins de un mois est un nouveau-né.
Substance indispensable à la croissance et au bon fonctionnement de l'organisme. Les besoins en vitamines sont normalement couverts par une alimentation variée. Dans les pays développés, seule la carence en vitamine D, chez le jeune enfant ou le vieillard peu exposés au soleil, justifie une supplémentation systématique. Un apport supérieur aux besoins, par des médicaments notamment, peut être à l'origine d'un surdosage et de troubles divers (vitamines A et D essentiellement).
Consultez l'article : Les vitamines.
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