DERMOVIT F

INFORMATION ON OUTER PACKAGING
{Cardboard box containing a PE tube 30 g}

1. NAME OF THE MEDICINAL PRODUCT

DERMOVIT F 25 mg/g, ointment
(Vitaminum F)

2. COMPOSITION OF ACTIVE SUBSTANCES

1 g of ointment contains: active substance - 25 mg of vitamin F

3. LIST OF EXCIPIENTS

Excipients: anhydrous eucerin, purified water, lavender oil.

4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS

ointment
30 g - EAN UCC Code: 5909990667598

5. METHOD AND ROUTE OF ADMINISTRATION

Apply to the skin.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
8. EXPIRY DATE
Expiry date:
Do not use the medicine after the expiry date stated on the packaging.

9. STORAGE CONDITIONS

Store below 25°C. Store in the original, tightly closed
container, protected from light.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVED FROM IT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:
WYTWÓRNIA EUCERYNY LABORATORIUM FARMACEUTYCZNE „COEL” S.J.
EZM KONSTANTY
ul. Wl. Zeleńskiego 45, 31-353 Kraków.

12. MARKETING AUTHORISATION NUMBER

Authorisation No R\2039

13. BATCH NUMBER

Batch number:

14. GENERAL AVAILABILITY CATEGORY

OTC - Medicinal product available without a prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE SYSTEM
dermovit F coel

17. OTHERS

Indications for use:
Topical ointment for use on the skin in children and adults for trophic skin disorders,
psoriasis, eczematous dermatitis, pressure ulcers, and burns.
Dosage and method of administration:
Apply a thin layer of ointment to the cleaned skin area once or twice daily. In acute
conditions, the skin may be treated several times a day.
Contraindications:
The product should not be used:

• in case of hypersensitivity to vitamin F or to any of the excipients;
• in the eyes or on mucous membranes.

Pregnancy and breastfeeding:
Consult a physician before use.
There is no data available regarding the use of the product in pregnant or breastfeeding women.
Adverse reactions:
Hypersensitivity reactions and contact dermatitis may occur.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a physician, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.