Bepanthen 5% Ointment - Skin Irritations / Diaper Rash - 30g

1. NAME OF THE MEDICINAL PRODUCT

BEPANTHEN 5%, ointment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dexpanthenol .................................. 5,0 g per 100 g of ointment. Notable excipient: lanolin (wool fat) For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ointment.

4. CLINICAL DATA

4.1 Therapeutic indications Skin irritations, especially in cases of diaper rash (red bottoms) in infants. 4.2. Posology and method of administration Cutaneous use. Apply by massaging gently once or several times a day. 4.3. Contraindications History of hypersensitivity to any of the components Infected or oozing dermatosis. 4.4. This medicine contains lanolin (wool fat) and may cause skin reactions (e.g. eczema). - Avoid contact with the eyes. 4.5. Interactions with other medicinal products and other forms of interaction The data available to date do not suggest the existence of clinically significant interactions. 4.6. Pregnancy and lactation Use with caution in pregnant or breastfeeding women, due to lack of available clinical data. In the case of application to the breasts of nursing mothers, the skin should be cleansed before each feeding. 4.7. Effects on ability to drive and use machines No effect on the ability to drive and use machines has been observed. 4.8. Adverse reactions Rare allergic skin reactions. 4.9. Overdose No cases of overdose have been reported.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties Pharmacotherapeutic class: SKIN PROTECTOR, ATC Code: D03AX. (D: dermatology). Dexpanthenol: constituent of coenzyme A. 5.2. Pharmacokinetic properties Not available. 5.3. Preclinical safety data Not available.

6. PHARMACEUTICAL DATA

6.1. List of excipients Protegin X*, petrolatum, wool grease, 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 packaging Aluminium tube of 3.5 g, 30 g, 80 g or 100 g. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORISATION HOLDER

BAYER HEALTHCARE SAS 220 AVENUE DE LA RECHERCHE 59120 LOOS

8. MARKETING AUTHORISATION NUMBER(S)

- 338 300-7: 3.5 g in tube (Aluminium). - 359 399-2: 30 g in tube (Aluminium). - 359 400-0: 80 g in tube (Aluminium). - 359 401-7: 100 g in tube (Aluminium). - 391 999-1 or 34009 391 999 1 7: 2 tubes of 100 g (Aluminium).

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

[To be completed by the holder]

10. DATE OF UPDATE OF THE TEXT

[to be completed by the holder] 11.

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.