Summary of Product Characteristics (SmPC) - Antipeol ointment, ST James ointment
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
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 CLINICAL PARTICULARS
4.4 Special warnings and precautions for use
Keep out of the sight and reach of children.
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
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
6.5 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
Aspar Pharmaceuticals Ltd Albany House, Acrewood way, St Albans, AL4 0JY,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0048
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/06/1988
10 DATE OF REVISION OF THE TEXT
28/06/2019