SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Morhulin Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Morhulin Ointment contains:

Zinc Oxide BP 38.0% w/w Cod Liver Oil BP 11.4% w/w

3 PHARMACEUTICAL FORM

Ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The treatment of minor wounds, minor excoriations, pressure sores, varicose ulcers, eczema and napkin rash.

4.2 Posology and method of administration

Adults, Children and the Elderly

Directions for use in wounds requiring a dressing.

The ointment should be applied thinly to clean dressing material, sufficient to cover the affected area and an area of healthy skin extending beyond the affected part. The dressing should then be pressed gently on to the wound.

Directions for use in superficial wounds:

The ointment can be used directly, one to three times a day.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

If symptoms persist, the doctor should be consulted. For external use only.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

Medicines should be avoided during pregnancy unless the anticipated benefits outweigh the risks.

4.7 Effects on ability to drive and use machines

None stated.

Undesirable effects

In rare cases, rashes may occur.

Overdose

In the case of deliberate or accidental ingestion of large quantities of Morhulin Ointment, symptomatic and supportive treatment should be provided.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Cod Liver Oil promotes the healing of wounds. The oil contains glyceryl ethers which have a direct action on tissues of mesenchymal origin which may explain the healing properties of Cod Liver Oil. Cod Liver Oil also contains Vitamin A which contributes to its healing effects. Zinc Oxide accelerates the removal of necrotic tissue from skin ulcers and has an established value in the treatment of minor skin wounds.

5.2 Pharmacokinetic properties

Morhulin Ointment is applied topically to the affected area.

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid Paraffin BP

Yellow Soft Paraffin BP Lanolin Anhydrous BP

Castor Oil BP

Diluted Sodium Hypochlorite Solution NF

6.2 Incompatibilities

None known.

6.3 Shelf life

Two years.

6.4 Special precautions for storage

Store at or below 25°C in a dry place.

6.5 Nature and contents of container

a)    Lacquered aluminium tube with white polypropylene flowerpot cap (20G).

b)    Plain aluminium tube with polyethylene flowerpot cap (50G).

c)    White polyethylene jar with white polyethylene wadless cap (350G).

6.6 Special precautions for disposal

None stated.

7    MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjordur Iceland.

8    MARKETING AUTHORISATION NUMBER(S)

PL 30306/0079

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

15 ^th January 2003

10 DATE OF REVISION OF THE TEXT

12/08/2008