SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Antipeol

St James’ Ointment

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Constituents: (% w/w)

Zinc Oxide 20.0 Ichthammol (1 in 3 dilution) 2.8 Salicylic Acid 0.1

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Ointment

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Soothing ointment for relief of minor skin problems

4.2    Posology and method of administration

For general use, smear the ointment around the affected area.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients

4.4 Special warnings and precautions for use

Keep out of the reach and sight of children.

4.5 Interaction with other medicinal products and other forms of interaction

There are no known interactions.

4.6 Fertility, Pregnancy and lactation

There is no data on use during pregnancy and lactation

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Salicylic Acid, Ichthammol and Urea can cause irritation to the skin. Wool fat (lanolin) may cause local skin reactions (e.g. contact dermatitis)

This product should be discontinued should this occur.

4.9 Overdose

Not applicable - for topical use.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties ATC code: D02AB

Zinc Oxide is a soothing and protective agent. Ichthammol and Salicylic Acid have bacteriostatic properties.

5.2 Pharmacokinetic properties

No data is available concerning the pharmacokinetic properties.

5.3 Preclinical safety data

Zinc Oxide, Ichthammol, Salicylic Acid and Urea are widely used in topical skin care products. Pharmacopoeial standard constituents are used. There has been no specific testing of these constituents and no preclinical data are available.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Liquid Paraffin Yellow Soft Paraffin Wool Fat Urea

Lavender Oil

6.2    Incompatibilities

None known

6.3 Shelf life

3 years from date of manufacture

6.4 Special precautions for storage

Store in a cool place

Nature and contents of container

Not all pack sizes may be marketed.

Compressible aluminium tubes containing 18, 37 or 93g of product.

6.6 Special precautions for disposal

No special instructions are necessary.

7    MARKETING AUTHORISATION HOLDER

Sestri Sales Limited 26 - 27 Capitol Way,

Colindale

London,

NW9 0EQ UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 05091/0001

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08/06/1988 / 11/11/2003

10 DATE OF REVISION OF THE TEXT

04/02/2015