Pharmafit Provence

Bayer Healthcare SAS

BEPANTHEN 5 % Pom 3T/100g

CIP / EAN code: 3400930261170

Product information from VIDAL.

Read the product information

Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
SmPC of 26/02/2024

BEPANTHEN 5 %, ointment


Forms and presentations

Ointment.


Composition

Dexpanthenol........................................................................................................................................................... 5,0 g

For 100 g of ointment.

Excipients with known effect: lanolin (wool fat), stearyl alcohol, cetyl alcohol 


Excipients:

Protegin X*, petrolatum, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.

*Composition of Protegin X: light liquid paraffin, petrolatum, microcrystalline wax (THG), glycerol monooleate, wool fat alcohols.



Indications

Skin irritation, particularly in cases of diaper rash (red buttocks) in infants.



Dosage and administration

Dosage

Apply by gently massaging one to several times a day.

Method of administration

Cutaneous use.



Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

Infected or weeping dermatosis.



Warnings and precautions

• Avoid any contact with the eyes.

• This medicine contains lanolin (wool fat), stearyl alcohol and cetyl alcohol. It may cause local skin reactions (for example contact dermatitis).



Interactions

The data available to date do not suggest the existence of clinically significant interactions.



Fertility, pregnancy and breastfeeding

To be used with caution in pregnant or breast-feeding women, due to no usable clinical data. In breast-feeding women, if applied to the breasts, clean the skin before each breastfeeding session.



Driving and using machines

BEPANTHEN 5 %, ointment has no or negligible influence on the ability to drive vehicles and use machines.



Adverse effects

Rare allergic skin reaction.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr..



Overdose

No cases of overdose have been reported.



Pharmacodynamics

Pharmacotherapeutic class: SKIN PROTECTANT, ATC code: D03AX. (D: dermatology).   

Dexpanthenol: component of coenzyme A.



Shelf life

3 years.



Special storage precautions

Store at a temperature not exceeding 25°C.



SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

No special requirements.



Prescription, supply and reimbursement

Marketing authorisation (AMM)
CIP 3400935939920 (T/30g).
CIP 3400935940179 (T/100g).
CIP 3400939199917 (2T/100g).
CIP 3400930123072 (T/100g+T/30g).
CIP 3400930261170 (3T/100g).
Non Remb Séc soc (T/30g, T/100g, 2T/100g, T/100g+T/30g, 3T/100g).
Collect (T/30g, T/100g).

Bayer Healthcare SAS
1 RUE CLAUDE BERNARD
59000 LILLE
Tel: 03 28 16 34 00 Tel (toll-free): 08 00 87 54 54
https://www.bayer.fr

Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.