1. DRUG NAME
BEPANTHEN 5%, ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexpanthenol , Protegin X®, vaseline, wool grease, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid paraffin, purified water.
3. PHARMACEUTICAL FORM
Ointment.
4. CLINICAL DATA
4.1. Therapeutic indications Skin irritations, especially in diaper rash (red buttocks) of infants. 4.2. Dosage and method of administration Dermal route. Apply with gentle massage once to several times daily. 4.3. Contraindications History of hypersensitivity to any of the components Infected or oozing dermatosis. 4.4. Special warnings and precautions for use - This drug contains lanolin (wool fat) and may cause skin reactions (e.g., eczema). - Avoid contact with the eyes. 4.5. Interactions with other drugs and other forms of interactions Available data to date do not suggest clinically significant interactions. 4.6. Pregnancy and lactation Use with caution in pregnant or lactating women due to lack of useable clinical data. In nursing women, if applied to the breasts, cleanse the skin before each feeding. 4.7. Effects on ability to drive and use machines No effects on ability to drive and use machines have been observed. 4.8. Adverse reactions Rare allergic skin manifestation. 4.9. Overdose No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties Pharmacotherapeutic class: skin protectant, ATC code: D03AX. (D: dermatology). Dexpanthenol: constituent of coenzyme A. 5.2. Pharmacokinetic properties Not provided. 5.3. Preclinical safety data Not provided.
6. PHARMACEUTICAL DATA
6.1. List of excipients Protegin X*, petroleum jelly, wool fat, white beeswax, almond oil, cetyl alcohol, stearyl alcohol, liquid kerosene, purified water. *Composition of Protegin X: light liquid kerosene, petrolatum, microcrystalline wax (THG), glycerol monooleate, wool fat alcohols. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Special storage precautions Store at a temperature not exceeding 25°C. 6.5. Nature and contents of outer package Aluminum 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 AUTHORIZATION HOLDER
BAYER HEALTHCARE SAS 220 AVENUE DE LA RECHERCHE 59120 LOOS
8. MARKETING AUTHORIZATION NUMBER(S)
- 338 300-7: 3.5 g in tube (Aluminum). - 359 399-2: 30 g in tube (Aluminum). - 359 400-0: 80 g in tube (Aluminum). - 359 401-7: 100 g in tube (Aluminum). - 391 999-1 or 34009 391 999 1 7: 2 tubes of 100 g (Aluminum).
.
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed by permittee]
10. TEXT UPDATE DATE
[to be completed by registrant]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION
Not applicable.
100% secure payment, Customer Satisfaction
Order shipped within 24 hours from Monday to Friday*
