Dexpanthenol 5% - Skin Irritation - Biogaran Conseil - 100 g

1. NAME OF THE MEDICINAL PRODUCT

DEXPANTHENOL BIOGARAN CONSEIL 5%, ointment

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dexpanthenol ............................................ 5.0 g per 100 g of ointment. Notable excipients: lanolin (wool fat), cetyl alcohol and stearyl alcohol. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ointment. Pale yellow 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 one of the components - Infected or oozing dermatosis. 4.4. Special warnings and precautions for use This medicinal product contains lanolin (wool fat), cetyl alcohol and stearyl alcohol and may cause local skin reactions (for example: 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 any clinically significant interaction. 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. Reporting of suspected adverse reactions The reporting of suspected adverse reactions after approval of the medicinal product is important. It allows continuous monitoring of the benefit/risk profile of the medicinal product. Health professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr. 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 applicable. 5.3. Preclinical safety data Not applicable.

6. PHARMACEUTICAL DATA

6.1. List of excipients Protegin XN*, petrolatum, wool grease, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water. *Composition of Protegin XN: liquid paraffin, petrolatum, microcrystalline wax, glycerol monooleate, wool fat alcohols. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Special storage precautions Store at a temperature not exceeding 25°C. After first opening: do not store the opened tube beyond 6 months. 6.5. Nature and contents of outer packaging 30 g or 100 g aluminium tube. Box of 1. 100 g aluminium tube. Box of 2. Not all presentations may be marketed. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORISATION HOLDER

BIOGARAN 15 BOULEVARD CHARLES DE GAULLE 92700 COLOMBES 8. MARKETING AUTHORISATION NUMBER(S) - 34009 279 477 7 3: 30 g in tube (Aluminium). Box of 1 - 34009 279 478 3 4 : 100 g tube (Aluminium). Date of first authorisation/renewal of authorisation [To be completed later by the holder] 10. DATE OF UPDATE OF TEXT [To be completed later by the holder] 11. DOSIMETRY Not applicable. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicinal product not subject to medical prescription.