WOODWARDS NAPPY RASH OINTMENT - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Woodwards Nappy Rash Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Woodwards Nappy Rash 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

Route of Administration

Topical

Adults, Children and the Elderly

Direction 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.

Direction for superficial wounds:

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

4.3 Contraindications

Lanolin hypersensitivity

4.4 Special warnings and precautions for use

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

Instruct patients not to smoke or go near naked flames – risk of severe burns.

Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard.

Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

None stated

4.6 Fertility, 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

4.8 Undesirable effects

In rare cases, rashes may occur.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9 Overdose

In the case of deliberate or accidental ingestion of large quantities of Woodwards Nappy Rash Cream, symptomatic and supportive treatment should be provided.

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

Not applicable to a topical preparation.

5.3 Preclinical safety data

None stated

6.1

6.2

Liquid paraffin BP

Yellow Soft paraffin BP

Lanolin Anhydrous BP

Castor Oil BP

Diluted Sodium Hypochlorite Solution BP

None stated

6.3

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 flower pot cap (20g, 25g and 50g).

b. Plain aluminium tube with polyethylene flower pot cap (20g, 25g and 50g).

c. White polyethylene jar with white polypropylene wadless cap (25g, 125g, 250g, 350g).

6.6 Special precautions for disposal

None stated

7 MARKETING AUTHORISATION HOLDER

Northumbria Pharma Ltd

Netpark

Thomas Wright Way

Sedgefield

County Durham

TS21 3FD

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 48259/0013

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

13/6/1995