Duocutan

INFORMATION ON IMMEDIATE PACKAGING
Tube

1. NAME OF THE MEDICINAL PRODUCT

Duocutan, 10 mg/g + 30 mg/g, gel
Clindamycinum + Benzoylis peroxidum

2. CONTENT OF ACTIVE SUBSTANCES

1 g of gel contains 0.01 g (1% w/w) clindamycin as clindamycin phosphate and 0.03 g (3% w/w) benzoyl peroxide as benzoyl peroxide with water.

3. LIST OF EXCIPIENTS

Excipients: carbomer, dimethicone 100, disodium lauryl sulfosuccinate, disodium edetate,
glycerol 85% (E 422), colloidal anhydrous silica, poloxamer 182, purified water, sodium
hydroxide (E 524) (for pH adjustment).

4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS

gel
30 g
60 g

5. METHOD AND ROUTE OF ADMINISTRATION

For topical application to the skin.
Read the entire leaflet before using the medicine.

6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT

KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.

7. OTHER SPECIAL PRECAUTION, IF NECESSARY

Warning: May bleach hair and coloured or dyed fabrics, furniture, and carpets.

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator (2°C-8°C). Do not freeze.
Shelf life after first opening of the tube: 2 months. After first opening of the tube, do not store at temperatures above 25°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED

MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH MEDICINAL PRODUCT, IF
APPLICABLE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

{ Logo of the marketing authorisation holder }

12. MARKETING AUTHORISATION NUMBER

Authorisation number 28599

13. BATCH NUMBER

Lot

14. GENERAL AVAILABILITY CATEGORY

Rp – Prescription-only medicine.
15. INSTRUCTIONS FOR USE
16. INFORMATION IN BRAILLE
17. UNIQUE IDENTIFIER – 2D CODE
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA