Woodwards Nappy Rash Ointment
SUMMARY OF PRODUCT 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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated
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
4.8 Undesirable effects
In rare cases, rashes may occur.
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 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
Not applicable to a topical preparation.
5.3 Preclinical safety data
None stated
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 BP
6.2 Incompatibilities
None stated
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 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
Ayrton Saunders Limited,
North Way,
Walworth Industrial Estate,
Andover,
SP10 5AZ United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0078
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/6/1995
10 DATE OF REVISION OF THE TEXT
30/09/2007