Bepanthen Pommade Ointment 5% – 30 g Tube

Skin irritations and diaper rash – From birth

Indications

Bepanthen 5% Ointment is a medicinal product indicated for the treatment of skin irritation, particularly diaper rash (red, irritated skin) in infants.

Skin irritations are caused by damage to the skin’s protective barrier. They may present as redness, flaking, or cracked skin, and can be triggered by friction, cold, or irritating products.

Who is it for?

• Infants, Children, Adolescents, Adults

• Pregnancy: use only on medical advice

• Breastfeeding: use only on medical advice

Form

• Ointment

Composition

Active ingredient (per 100 g):

• Dexpanthenol: 5 g

Other ingredients:
Protegin X®, petrolatum, wool fat (lanolin), white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.

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

Directions for use

For all ages, apply once or several times daily using a gentle massage.

Contraindications and warnings

• Do not use in case of hypersensitivity to any ingredient.

• Do not use on weeping or infected skin conditions.

• Contains lanolin (wool fat), which may cause skin reactions (e.g., eczema).

If symptoms persist beyond 5 days or worsen, consult a healthcare professional.

Pregnancy and breastfeeding: always seek medical advice.
If applied to the breasts during breastfeeding, clean the skin thoroughly before each feeding.

Please read the following full disclosure before purchasing or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Last updated: 30/05/2024

1. NAME OF THE MEDICINAL PRODUCT

BEPANTHEN 5% ointment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dexpanthenol ......................................................................................................................... 5.0 g

Per 100 g of ointment.

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

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ointment.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Skin irritations, particularly diaper rash (red buttocks) in infants.

4.2. Posology and method of administration

Posology
Apply with gentle massage once or several times daily.

Method of administration
Cutaneous use.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Infected or weeping dermatoses.

4.4. Special warnings and precautions for use

• Avoid contact with the eyes.
• This medicinal product contains lanolin (wool fat), stearyl alcohol, and cetyl alcohol. It may cause local skin reactions (e.g. contact dermatitis).

4.5. Interaction with other medicinal products and other forms of interaction

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

4.6. Fertility, pregnancy and breastfeeding

Use with caution during pregnancy or breastfeeding due to the lack of exploitable clinical data.
In breastfeeding women, if applied to the breasts, clean the skin before each feeding.

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

Rare allergic skin reactions.

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

4.9. Overdose

No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: SKIN PROTECTANT, ATC code: D03AX (D: Dermatology).

Dexpanthenol: component of coenzyme A.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of 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.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store at a temperature not exceeding 25°C.

6.5. Nature and contents of container

Aluminum tube of 3.5 g, 30 g, 80 g, or 100 g.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

BAYER HEALTHCARE SAS
1 Rue Claude Bernard
59000 Lille
France

8. MARKETING AUTHORIZATION NUMBER(S)

• 34009 338 300 7 6: 3.5 g aluminum tube
• 34009 359 399 2 0: 30 g aluminum tube
• 34009 359 400 0 1: 80 g aluminum tube
• 34009 359 401 7 9: 100 g aluminum tube
• 34009 391 999 1 7: 2 × 100 g aluminum tubes
• 34009 301 230 7 2: 1 × 100 g + 1 × 30 g aluminum tubes
• 34009 302 611 7 0: 3 × 100 g aluminum tubes

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

[To be completed later by the marketing authorization holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the marketing authorization holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND SUPPLY

Medicinal product not subject to medical prescription.